Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710602

FEI Number

3003513129

Entity Name

GE MEDICAL SYSTEMS (CHINA) CO., LTD.

City/State/Country

WUXI Jiangsu, CN

Establishment Address

NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE, WUXI Jiangsu 214028, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200119

PMA Number

N/A

All Registered Proprietary Names

Nellcor OxiMax, 3m/10ft 2021406-002 SpO2 Interconnect cable 2021406-001 SpO2 Interconnect cable Nellcor OxiMax, 1.2m/3.9ft ML6-15-D IC5-9-D L2-9VN-D L2-9-D C1-6VN-D L3-12-D C2-9VN-D 6S-D L8-18i-D LOGIQ E10 RAB6-D 6Tc-RS RIC5-9-D ML4-20-D M5Sc-D ML4-20VN-D C3-10-D P6D BE9CS-D C2-9-D P2D C1-6-D iC5-9-D 6Vc-D ML6-15-D C2-9-D 8C 12S-D 4Vc-D P2D C1-6-D Vivid E80 C3-10-D 6Tc-RS 10T-D 4V-D 11L-D 9T-RS Vivid E90 L8-18i-D M5Sc-D 6S-D P6D Vivid E95 9T 9L-D 4D ICE catheter 6VT-D 12L-RS Venue 6Tc-RS 9L-RS C1-5-RS E8C-RS 8C-RS L8-18i-RS 3Sc-RS L12n-RS L4-12t-RS 6S-RS 3Sc-RS 6S-RS 12L-RS E8C-RS L4-20t-RS L4-12t-RS 9L-RS Venue Fit ML6-15-RS 8C-RS L10-22-RS C1-5-RS L8-18i-RS 6Tc-RS 12S-RS L8-18i-RS LK760-RS 6S-RS L6-12-RS 4C-RS Versana Balance 12L-RS 8C-RS RAB2-6-RS E8C-RS 3Sc-RS 12S-RS E8Cs-RS Datex-Ohmeda S/5 EEG Module E-EEG Datex-Ohmeda S/5 EEG Headbox AEP Ear Tips for Earphone Set (8001233) EEG Lead set 3 (898052) EEG Lead set 1 (898050) LOGIQ e 12L-RS L10-22-RS 8C-RS 9L-RS C1-5-RS L8-18i-RS 6S-RS E8C-RS L4-12t-RS 3Sc-RS L4-12t-RS ML6-15-RS 12S-RS M5Sc-RS Venue L4-20t-RS 3Sc-RS L12n-RS 6S-RS L10-22-RS 8C-RS 12L-RS C1-5-RS C2-9-RS L8-18i-RS 6Tc-RS E8C-RS 9L-RS Venue Sprint 4C-RS 6S-RS RAB2-6-RS 8C-RS L8-18i-RS E8Cs-RS E8C-RS LOGIQ F8 Expert LOGIQ F6 BE9CS-RS LOGIQ F8 L6-12-RS 3Sc-RS L6-12-RS Vivid T8 8C-RS 4C-RS 3Sc-RS 9T-RS 12L-RS 6S-RS 6Tc-RS L8-18i-RS 9L-RS P2D 12S-RS E8C-RS RAB6-D RIC10-D RSP6-16-D RM6C M5Sc-D C2-9-D RIC12-D 9L-D RIC5-9-D L8-18i-D RM7C C1-6-D Voluson Expert 22 Voluson Expert 20 ML6-15-D RIC6-12-D 12S-D IC5-9-D 6S-D 11L-D Voluson Expert 18 eM6C G3 E8C-RS L4-12t-RS 9L-RS M5Sc-RS 6S-RS 12L-RS L12n-RS 12S-RS L8-18i-RS Venue ML6-15-RS 3Sc-RS 6Tc-RS C1-5-RS L4-20t-RS 8C-RS L10-22-RS Carestation 750 Carestation 750c Carestation 750/750c Carestation 750 A1 Carestation 750c A1 C2-9VN-D C1-6-D LOGIQ E10 IC5-9-D L4-20t-D M5Sc-D L8-18i-D ML4-20VN-D L2-9-D C3-10-D 6S-D BE9CS-D 6Tc-RS P2D C1-6VN-D L2-9VN-D RIC5-9-D RAB6-D C2-9-D L3-12-D ML4-20-D ML6-15-D P6D NEUROMUSCULAR TRANSMISSION MODULE, E-NMT DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT NMT Regional Block Adapter 0.5m/1.5ft NMT MechanoSensor 0.3m/1ft NMT ElectroSensor 0.3m/1ft NMT Pediatric MechanoSensor 0.3m/1ft NMT Sensor Cable 3.3m/11ft NMT Electrodes, Solid Gel, Ag/AgCl, 30/pkg P2D C1-5-RS 4C-RS 8C-RS L8-18i-RS 9T-RS 6S-RS 3Sc-RS 9L-RS Vivid iq 6Tc-RS L4-20t-RS E8Cs-RS M5Sc-RS 6VT-D Vivid iq v206 to v208 SW only UPG 10T-D 12S-RS ML6-15-RS 12L-RS Vivid iq v206 to v208 HW+SW UPG Voluson E6 Voluson E8 P2D C1-5-D eM6C G2 9L-D C1-6-D RAB6-D L2-9-D IC5-9-D RM7C C4-8-D Voluson E10 RSP6-16-D RM6C 11L-D C2-9-D ML6-15-D RAB2-5-D eM6C G3 RNA5-9-D RIC6-12-D eM6C P6D IC9-D RIC5-9-D M5Sc-D ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. L10-22-RS 12S-RS 6Tc-RS L8-18i-RS L4-20t-RS Venue Go C2-9-RS 6S-RS E8C-RS M5Sc-RS Venue L12n-RS ML6-15-RS 12L-RS L4-12t-RS 3Sc-RS 8C-RS C1-5-RS Venue Sprint 9L-RS Venue Fit RAB2-6-RS RAB4-8-RS Voluson i E8C-RS 8C-RS Voluson e RAB2-5-RS 4C-RS RIC5-9W-RS RNA5-9-RS 12L-RS 9L-RS LK760-RS 3Sc-RS 4C-RS 8C-RS E8C-RS 12L-RS LOGIQ V2 L6-12-RS LOGIQ V1 CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 4Vc-D iC5-9-D 9L-D 11L-D C3-10-D P2D Vivid Pioneer M5Sc-D 9VT-D 6Sc-D C1-6-D 10-D 6VT-D 6S-D 12S-D 6Vc-D L8-18i-D C2-9-D 9L-D RAB6-D C2-9-D C1-5-D C1-6-D ML6-15-D IC5-9-D LOGIQ S8 P6D L8-18i-D P2D L3-12-D RIC5-9-D 6S-D 6Tc-RS BE9CS-D RSP6-16-D C3-10-D 11L-D 12S-RS L8-18i-RS L12n-RS 9L-RS L4-20t-RS Venue 12L-RS E8C-RS 6S-RS 3Sc-RS ML6-15-RS 8C-RS L4-12t-RS 6Tc-RS C1-5-RS L10-22-RS Venue Trident ML4-20-D L8-18i-D BE9CS-D 6Tc-RS C1-6-D LOGIQ E10s RIC5-9-D L2-9-D 6S-D C3-10-D P2D C2-9VN-D L2-9VN-D L3-12-D ML4-20VN-D ML6-15-D P6D RAB6-D C1-6VN-D C2-9-D IC5-9-D M5Sc-D LOGIQ Fortis LOGIQ E10s R2 to R3 UPG 9L-RS 12L-RS RAB2-6-RS Voluson S10 8C-RS C1-5-RS Voluson S8t Voluson S10 Expert 4C-RS 3Sc-RS Voluson S8 C2-9-RS 12S-RS IC9B-RS IC9-RS RIC5-9A-RS ML6-15-RS Voluson S6 ML6-15 9L-D 6S-D C1-6-D 8C 11L-D IC5-9-D BE9CS BE9CS-D C1-5-D L3-12-D P6D P2D LOGIQ S7 Expert RIC5-9-D RAB4-8-D L8-18i-D 6Tc-RS C3-10-D 3Sc-RS IC9B-RS C1-5-RS IC9-RS 12L-RS E8C-RS 4C-RS RAB6-RS Voluson SWIFT RAB2-6-RS Voluson SWIFT+ RIC5-9A-RS 6S-D 10T-D Vivid E90 M5Sc-D 12S-D 11L-D 6Tc-RS 9T-RS iC5-9-D 9L-D C2-9-D 9T Vivid E95 ML6-15-D 6VT-D C3-10-D P2D 4V-D P6D 8C Vivid E80 C1-6-D L8-18i-D 6Vc-D 4Vc-D 8C-RS Voluson S6 BT16 RAB6-RS E8C-RS IC9-RS Voluson S10 12L-RS Voluson S series Voluson S8 BT16 Voluson S8 3Sc-RS Voluson S6 9L-RS 12S-RS Voluson S series BT16 Voluson S10 BT16 RIC5-9A-RS ML6-15-RS C1-5-RS 4C-RS IC5-9-D LOGIQ E10 RIC5-9-D C2-9-D L2-9-D ML6-15-D L8-18i-D C2-9VN-D 12S-D BE9CS-D P6D C1-6VN-D L3-12-D RAB6-D C3-10-D L2-9VN-D L4-20t-D M5Sc-D C1-6-D ML4-20-D P2D ML4-20VN-D 6S-D 6Tc-RS B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor ML6-15-D P6D C2-9-D RIC5-9-D LOGIQ E10s R2R3 to R4 SW Upgrade W M5Sc-D LOGIQ Fortis R3 to R4 SW Upgrade W BE9CS-D P2D L3-12-D IC5-9-D C2-9VN-D L4-20t-D RAB6-D 6Tc-RS LOGIQ Fortis ML4-20VN-D L2-9VN-D LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ E10s 6S-D C1-6VN-D L2-9-D ML4-20-D LOGIQ Fortis R3 to R4 HW Upgrade C3-10-D LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade C1-6-D L8-18i-D LOGIQ E10s R2R3 to R4 HW Upgrade W RIC5-9A-RS 3Sc-RS 12L-RS E8C-RS Voluson P8 IC9-RS Voluson P6 4C-RS IC9B-RS RAB2-6-RS P6D 11L-D 9T 9L-D 6VT-D 6S-D Vivid E80 P2D 8C M5Sc-D 6Tc-RS 9T-RS 4V-D 10T-D Vivid E90 C1-6-D 4Vc-D C2-9-D Vivid E95 C3-10-D iC5-9-D 12S-D L8-18i-D L4-20t-RS L10-22-RS 9L-RS Venue Go 8C-RS E8C-RS L8-18i-RS 3Sc-RS 6S-RS ML6-15-RS L4-12t-RS M5Sc-RS 12L-RS 6Tc-RS 12S-RS C1-5-RS C1-6-D RNA5-9-D RAB6-D RIC5-9-D IC9-D Voluson E8 RIC6-12-D IC5-9-D Voluson E10 C4-8-D ML6-15-D eM6C G2 Voluson E6 C2-9-D RAB2-5-D 9L-D RM6C RSP6-16-D eM6C C1-5-D 11L-D 12L-RS E8C-RS 3Sc-RS RIC5-9A-RS RAB2-6-RS 4C-RS Voluson P6 Voluson P8 IC9-RS LOGIQ S20 LOGIQ S20 Express C1-6VN-D ML6-15-D 12S-D M5Sc-D C2-9VN-D LOGIQ Vita Power L8-18i-D L2-9VN-D LOGIQ Vita Express P2D L4-20t-D P6D IC5-9-D L2-9-D LOGIQ S20 Plus 6Tc-RS RIC5-9-D LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power RAB6-D LOGIQ Vita L3-12-D C1-6-D 6S-D C2-9-D C3-10-D BE9CS-D LOGIQ Vita Pro L8-18i-D P6D LOGIQ E10 C1-6VN-D C3-10-D RIC5-9-D C1-6-D M5Sc-D 6S-D IC5-9-D 6Tc-RS L2-9VN-D ML6-15-D L2-9-D BE9CS-D RAB6-D P2D C2-9VN-D C2-9-D 6S-RS E8Cs-RS L6-12-RS E8C-RS Versana Essential RAB2-6-RS 8C-RS 3Sc-RS LK760-RS 4C-RS C1-6-D C1-6VN-D C2-9-D C1-5-D 6S-D M5Sc-D C3-10-D RIC5-9-D ML6-15-D L3-12-D L8-18i-D RSP6-16-D IC5-9-D LOGIQ S8 C2-9VN-D 9L-D 6Tc-RS P2D 11L-D P6D RAB6-D BE9CS-D Carestation 650c Carestation 620 Carestation 650 A1 Carestation 620 A1 Carestation 620/650/650c Carestation 650 Carestation 650c A1 CARESCAPE R860 Ventilator R860 CARESCAPE R860 9T-RS M5Sc-RS 6Tc-RS E8Cs-RS C1-5-RS Vivid iq L8-18i-RS 4C-RS ML6-15-RS 6VT-D 9L-RS 6S-RS P2D 12S-RS 12L-RS 3Sc-RS 8C-RS L8-18i-RS E8Cs-RS 12S-RS Versana Premier 6S-RS LK760-RS E7C8L-RS 4C-RS L3-12-RS L6-12-RS C1-5-RS BE9CS-RS 12L-RS RIC5-9A-RS RAB2-6-RS E8C-RS 3Sc-RS 8C-RS 9L-RS Voluson P6 E8C-RS 12L-RS RAB2-6-RS 4C-RS 3Sc-RS Voluson P8 RIC5-9A-RS IC9-RS 6S-RS 9T-RS C1-5-RS ML6-15-RS 12L-RS 12S-RS E8Cs-RS P2D 6Tc-RS Vivid T9 4C-RS Vivid T8 L8-18i-RS L6-12-RS 3Sc-RS 8C-RS 9L-RS E8C-RS LK760-RS Versana Premier 8C-RS 12L-RS 12S-RS RAB2-6-RS L8-18i-RS 3Sc-RS 6S-RS RIC5-9A-RS E8C-RS 4C-RS L6-12-RS E7C8L-RS BE9CS-RS E8Cs-RS C1-5-RS C1-6-D IC9-D RSP6-16-D eM6C RIC6-12-D 11L-D RAB6-D C2-9-D Voluson E8 RNA5-9-D C1-5-D RIC5-9-D Voluson E6 9L-D ML6-15-D RM6C C4-8-D RAB2-5-D eM6C G2 M5Sc-D Voluson E10 IC5-9-D 12S-RS 9L-RS L4-20t-RS E8C-RS 6Tc-RS C2-9-RS L6-12-RS IC9-RS L4-12t-RS L10-22-RS 6S-RS C1-5-RS L8-18i-RS 4C-RS LOGIQ e 3Sc-RS 12L-RS 8C-RS ML6-15-RS MAC 7 Resting ECG Analysis System Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00 PiCCO Injectate Sensor Cable (M1182448) PiCCO Continuous Cardiac Output Cable (M1154585) CARESCAPE R860 6Tc-RS 12S-D C2-9-D iC5-9-D 8C 9T-RS 9T P2D 11L-D Vivid E90 4V-D C1-6-D P6D L8-18i-D Vivid E95 6VT-D 9L-D 6S-D M5Sc-D Vivid E80 10T-D E8C-RS L8-18i-RS 6Tc-RS 9L-RS 3Sc-RS L4-12t-RS 8C-RS C1-5-RS 12L-RS Venue Go 6S-RS RAB2-6-RS 6Tc-RS L6-12-RS C1-5-RS P2D LOGIQ P9 8C-RS M5sc-RS 9L-RS ML6-15-RS C1-6-D L8-18i-RS L3-12-RS 3Sc-RS L4-12t-RS P6D L10-22-RS 12L-RS LOGIQ P10 E8CS-RS 6S-RS BE9CS-RS LOGIQ P8 C3-10-D E8C-RS IC9-RS 12S-RS RIC5-9A-RS E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG Multi-Absorber canister reusable Absorber canister assembly ABS Reusable Absorbent Canister Reusable Absorber Canister Reusable Absorbent Canister Reusable CO2 Absorber Canister Multi Absorber Canister CBS Reusable Absorbent Canister reusable 11L-D IC9-D 9L-D C1-5-D RSP6-16-D C1-6-D eM6C G2 RM7C eM6C Voluson E10 RAB2-5-D ML6-15-D C2-9-D RIC6-12-D IC5-9-D Voluson E6 RIC5-9-D Voluson E8 RNA5-9-D M5Sc-D RM6C L2-9-D M5Sc-D P6D 6VT-D Vivid S70N C2-9-D 9T-RS C1-5-D 12S-D IC5-9-D P2D ML6-15-D 6S-D 6Tc-RS Vivid S60N C3-10-D 11L-D L8-18i-D 9L-D C1-6-D 10T-D 4Vc-D 3Sc-RS IC5-9-D 9L-D M5Sc-D L8-18i-D Voluson Expert 18 RAB6-D RM7C RIC5-9-D 12S-D RM6C 6S-D RIC6-12-D 11L-D C2-9-D C1-6-D RIC10-D RAB7-D ML6-15-D Voluson Expert 22 RIC12-D RSP6-16-D Voluson Expert 20 eM6C G3 12L-RS E8C-RS 6S-RS 3Sc-RS Versana Balance 8C-RS E8Cs-RS L6-12-RS 4C-RS LK760-RS RAB2-6-RS B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe LK760-RS L6-12-RS 3Sc-RS 6S-RS E8C-RS 12L-RS 8C-RS 12S-RS Versana Active RAB2-6-RS 4C-RS 9L-RS L8-18i-RS E8Cs-RS Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Disposable Infant Skin Temperature Probe Giraffe Panda Disposable Infant Skin Temperature Probe Panda Warmer Vscan Extend G3S, deep scanning transducer G8L, shallow scanning transducer Vscan Extend dual probe dual probe P6D Voluson E8 11L-D Voluson E series BT15 Voluson E6 RIC5-9-D IC5-9-D RAB6-D RSP6-16-D Voluson E10 C4-8-D ML6-15-D eM6C RNA5-9-D RAB2-5-D RIC6-12-D P2D RM6C Voluson E series C1-5-D 9L-D Achilles OsteoReportN 9L-RS L8-18i-RS 3Sc-RS 6S-RS 12S-RS 8C-RS ML6-15-RS 6Tc-RS C1-5-RS P2D 4C-RS 6VT-D 12L-RS E8Cs-RS 9T-RS Vivid iq M5Sc-RS E8C-RS C1-5-RS L4-12t-RS Venue Go 8C-RS M5Sc-RS L10-22-RS 12S-RS 12L-RS 3Sc-RS C2-9-RS L8-18i-RS L4-20t-RS 6S-RS ML6-15-RS 6Tc-RS 9L-RS 9L t739 ERB 11L 12L 4C E8C 10L E8CS 3Sc-RS L8-18i-RS ML6-15-RS L4-12t-RS 12L-RS 9L-RS L4-20t-RS 12S-RS L10-22-RS 6Tc-RS LOGIQ e 8C-RS 6S-RS 4C-RS E8C-RS C1-5-RS GE ENTROPY SENSOR (REFM1038681) GE ENTROPY CABLE (REF M1050784) E8Cs-RS E8C-RS LK760-RS L6-12-RS 3Sc-RS 6S-RS 4C-RS 8C-RS L8-18i-RS 9L-RS Versana Active 12S-RS 12L-RS RAB2-5-D LOGIQ E9 M6C-D RIC5-9-D RSP6-16-D 3CRF P2D RNA5-9-D L8-18i-D P6D C2-9VN-D 9L-D RAB4-8-D 11L-D C1-6-D IC5-9-D RAB6-D C1-5-D 6S-D C2-9-D LOGIQ E9 XDClear 2 C3-10-D C1-6VN-D S4-10-D 12L-RS E8C-RS 9L-RS 12S-RS Venue Fit C2-9-RS 8C-RS L10-22-RS L4-20t-RS 6S-RS 6Tc-RS 3Sc-RS L4-12t-RS L8-18i-RS M5Sc-RS ML6-15-RS C1-5-RS M5Sc-D RAB6-D Voluson Signature 20 Voluson Signature 18 11L-D C2-9-D IC5-9-D C1-5-D 9L-D RIC5-9-D ML6-15-D C1-6-D Vscan Extend G3S, Deep Scanning Transducer G8L, Shallow Scanning Transducer Vscan Extend dual probe dual probe TRAM 2001 Module 2006644-001 SpO2 Interconnect cable Nellcor OxiSmart, 2.9m/9.5ft L3-12-D C2-9-D RIC5-9-D L2-9-D P2D ML4-20VN-D L2-9VN-D C1-6-D M5Sc-D LOGIQ E10s ML6-15-D C2-9VN-D 6Tc-RS 6S-D RAB6-D IC5-9-D C3-10-D L4-20t-D ML4-20-D L8-18i-D BE9CS-D C1-6VN-D 12S-D P6D 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L 3Sc-RS P2D C1-5-RS 6Tc-RS L6-12-RS ML6-15-RS 9L-RS L8-18i-RS 8C-RS 6S-RS Vivid T9 L4-20t-RS M5Sc-RS Vivid T8 E8C-RS 12L-RS 4C-RS 9T-RS Vivid T8 T9 v206 to v208 SW only UPG 12S-RS E8Cs-RS MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System 3Sc-RS E8C-RS LOGIQ P9 8C-RS ML6-15-RS L8-18i-RS E8CS-RS P6D L10-22-RS 4C-RS L4-12t-RS 12L-RS 6S-RS 9L-RS C1-5-RS RIC5-9A-RS RAB2-6-RS L12n-RS LOGIQ P7 12S-RS L6-12-RS BE9CS-RS RAB2-6-RS 12L-RS 9L-RS Voluson SWIFT+ RAB6-RS 4C-RS Voluson SWIFT IC9B-RS E8C-RS 3Sc-RS RIC5-9A-RS IC9-RS C1-5-RS 12S-RS P2D 6S-RS E8Cs-RS (only for Vivid T9) 4C-RS 3Sc-RS 9T-RS E8C-RS 12L-RS L8-18i-RS 12S-RS L6-12-RS Vivid T8 9L-RS C1-5-RS (only for Vivid T9) 6Tc-RS Vivid T9 8C-RS 11M3 Voluson S10 Expert RAB2-6-RS 4C-RS 12L-RS Voluson S10 8C-RS RIC5-9A-RS 3Sc-RS C2-9-RS C1-5-RS ML6-15-RS IC9-RS 12S-RS 9L-RS Voluson S8t Voluson S8 Voluson S6 6S-D ML6-15-D IC5-9-D P6D C1-6-D 9L-RS RIC5-9-D 12S-RS C1-6VN-D M5Sc-D RAB6-D P2D LOGIQ Totus L3-12-D C3-10-D E8C-RS L6-12-RS 3Sc-RS ML6-15-RS 12L-RS E8CS-RS LOGIQ P9 L8-18i-RS 9L-RS L10-22-RS 8C-RS 12S-RS L4-12t-RS LOGIQ P7 RIC5-9A-RS 6S-RS RAB2-6-RS C1-5-RS 4C-RS BE9CS-RS C2-9-D M5Sc-D 9T-RS 6Tc-RS IC5-9-D C3-10-D 6S-D P6D 11L-D 9L-D 3Sc-RS Vivid S60N P2D C1-6-D 6VT-D Vivid S70N 12S-D 10T-D C1-5-D M5Sc-D 6VT-D 9T-RS Vivid S70N 12S-D P6D 9L-D IC5-9-D C1-6-D L8-18i-D ML6-15-D Vivid S60N 6Tc-RS P2D C2-9-D 6S-D C3-10-D 10T-D 3Sc-RS 11L-D M5Sc-D 11L-D C2-9-D 6Tc-RS C3-10-D Vivid S70N P2D C1-5-D P6D 6VT-D 9T-RS Vivid S60N IC5-9-D L8-18i-D C1-6-D 10T-D 3Sc-RS 12S-D 9L-D 6Tc C1-6-D 12S-D 6VT-D 9L-D P2D Vivid S70 M5Sc-D 6Tc-RS 3Sc-RS Vivid S60 11L-D P6D 9T-RS C3-10-D 6S-D C2-9-D eM6CG2 RAB6-D C1-5-D RM6C Voluson E6 IC9-D RAB2-5-D C4-8-D RIC6-12-D 9L-D IC5-9-D Voluson E series BT16 Voluson E8 RSP6-16-D ML6-15-D 11L-D Voluson E6 BT16 Voluson E10 BT16 eM6C RIC5-9-D Voluson E series Voluson E10 Voluson E8 BT16 ML6-15-D L4-20t-D BE9CS-D RAB6-D L8-18i-D P2D C2-9VN-D IC5-9-D C1-6VN-D LOGIQ Fortis 6S-D L3-12-D RIC5-9-D 12S-D P6D M5Sc-D 6Tc-RS 9L-D C1-6-D C2-9-D C3-10-D L2-9-D L2-9VN-D L8-18i-RS C1-5-RS L4-12t-RS 12L-RS L10-22-RS Venue Go E8C-RS 9L-RS 8C-RS 6S-RS 3Sc-RS 12S-RS ML6-15-RS L4-20t-RS 6Tc-RS P2D 9L-D 11L-D 4Vc-D Vivid S70N 6Tc-RS C3-10-D Vivid S60N 3Sc-RS ML6-15-D C1-5-D 6S-D C1-6-D 12S-D 9T-RS 6VT-D Vivid S70N Dimension P6D L8-18i-D IC5-9-D C2-9-D M5Sc-D Venue 50 L8-18i-SC E8CS-SC 3S-SC 4C-SC L12n-SC 12L-SC 6S-D P2D C3-10-D IC5-9-D C2-9VN-D M5Sc-D L2-9-D L2-9VN-D C2-9-D 6Tc-RS P6D RIC5-9-D BE9CS-D L3-12-D RAB6-D C1-6VN-D C1-6-D L8-18i-D LOGIQ E10s ML6-15-D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-03-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-03-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-03-11
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2021-03-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-05-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-05-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-05-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-12-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-12-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-12-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2008-01-29
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2008-01-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2008-01-29
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-01-29
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2008-01-29
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-01-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-02-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-03-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-03-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-03-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-03-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-28
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2023-03-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-10
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2008-01-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-09-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-09-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-09-24
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-06-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-10-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-10-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-10-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-01-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-01-15
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-04-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-04-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-04-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-04-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-04-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-04-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-04-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-04-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-04-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-04-14
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2023-04-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-04-14
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2023-04-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-04-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-04-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-04-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-04-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2023-04-14
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2023-04-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2023-04-14
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-04-14
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2023-04-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-04-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-08-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-10-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-10-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-10-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-08-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-08-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-08-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-01-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-01-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-01-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-02-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-10-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-10-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-10-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-08-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-08-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-08-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-12-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-12-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-12-03
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-04
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2022-04-04
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-04
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-04
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-04
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-04
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-04
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-02-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-02-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-02-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-10-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-10-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-10-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-04-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-04-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-03-26
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-03-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-03-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-04-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-04-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-04-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2016-01-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-06-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-04-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-04-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-04-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-10-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-10-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-10-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-01-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2026-01-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-01-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-01-30
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2016-03-21
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2016-03-21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-01-20
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2022-01-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-01-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-01-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-01-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-03-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-03-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-03-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-10-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-10-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-10-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-10-08
BSF	Absorber, Carbon-Dioxide	Anesthesiology	Class 1	868.5310	2002-04-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-06-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-06-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-06-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-08-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-05-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-05-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-05-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-05-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-05-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-05-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-05-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-05-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-05-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-05-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-05-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-05-14
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2026-05-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2016-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-06-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-06-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-06-18
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-02-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-09-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-09-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-09-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-20
MUA	Bone Sonometer	Radiology	Class 2	892.1180	2013-05-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-05-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-12-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-12-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-12-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2007-11-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-11-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2007-11-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-01-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-03-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-03-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-03-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-06-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-13
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-12-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-12-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-12-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-09-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-09-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-09-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-21
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-10-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-10-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-10-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-02-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-06-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-03-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-03-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-03-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-12-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-12-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-12-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-12-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-05-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-05-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-05-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-10-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-10-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-10-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-13
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-12-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-12-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-12-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710602. Last updated year: 2026. Please use registration number 9710602 when referencing this establishment in official correspondence.