Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612283

FEI Number

3002808529

Entity Name

GE Healthcare Japan Corporation

City/State/Country

HINO-SHI Tokyo, JP

Establishment Address

7-127, Asahigaoka 4-chome, HINO-SHI Tokyo 191-8503, JP

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

K180374

PMA Number

N/A

All Registered Proprietary Names

6S-D LOGIQ Totus C1-6VN-D ML6-15-D L6-24-D C1-6-D P2D L4-20t-D M5Sc-D C2-9-D 6Tc-RS P6D IC5-9-D RAB6-D L3-12-D C3-10-D RIC5-9-D 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 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 True Enhance DL 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 E8Cs-RS ML6-15-RS C1-5-RS E8C-RS 4C-RS M5Sc-RS 6S-RS Vivid T8 T9 v204 v205 to v206 UPG SW only 9L-RS Vivid T8 T9 v204 v205 to v206 UPG L6-12-RS 12L-RS Vivid T9 Vivid T8 L8-18i-RS P2D 6Tc-RS 3Sc-RS 8C-RS L4-20t-RS 12S-RS 9T-RS LK760-RS 3Sc-RS 4C-RS 8C-RS E8C-RS 12L-RS LOGIQ V2 L6-12-RS LOGIQ V1 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 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 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 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 Deep Learning Image Reconstruction 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 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 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 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 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 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 Deep Learning Image Reconstruction 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 12L-RS E8C-RS 6S-RS 3Sc-RS Versana Balance 8C-RS E8Cs-RS L6-12-RS 4C-RS LK760-RS RAB2-6-RS 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 Vivid iq 8C-RS 9T-RS M5Sc-RS 3Sc-RS 6Tc-RS 12S-RS ML6-15-RS C1-5-RS 9L-RS P2D 4C-RS 12L-RS L8-18i-RS 6VT-D 6S-RS E8Cs-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 True Definitional DL Revolution UPG 5 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 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 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 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 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 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 NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L 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 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 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 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 L12n-RS C1-5-RS 8C-RS 12L-RS E8C-RS 3Sc-RS 9L-RS Venue 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 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 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 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 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 C2-9-D Probe C2-9-D Transducer C2-9-D 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 RSP6-16-D RIC10-D RM7C RAB6-D eM6C G3 IC5-9-D Voluson Expert 20 M5Sc-D Voluson Expert 22 RIC5-9-D 6S-D 9L-D RIC6-12-D RAB7-D C2-9-D 12S-D C1-6-D RM6C 11L-D RIC12-D Voluson Expert 18 ML6-15-D L8-18i-D Voluson P6 E8C-RS 12L-RS RAB2-6-RS 4C-RS 3Sc-RS Voluson P8 RIC5-9A-RS IC9-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 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 Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660Pro Optima CT660sPro Optima CT660J Optima CT660 Revolution EVO 33 kW/48 kW Optima CT660s Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Console Generation Upgrade 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 12L-SC 4C-SC 3S-SC L8-18i-SC Venue 50 E8CS-SC MTZ Biopsy Guide Attachment E8C Reusable Guide Attachment ERB7/ERB Biopsy Attachment 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 Versana Premier E8C-RS 9L-RS 6Tc-RS L6-12-RS 6S-RS 12L-RS L8-18i-RS E8Cs-RS LOGIQ F 3Sc-RS C1-5-RS L3-12-RS E7C8L-RS 8C-RS RIC5-9A-RS 4C-RS L4-20t-RS BE9CS-RS RAB2-6-RS Versana Premier Lotus 12S-RS LK760-RS IC9-RS RIC5-9A-RS 3Sc-RS 12L-RS E8C-RS Voluson P8 IC9-RS Voluson P6 4C-RS IC9B-RS RAB2-6-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 Enhanced Extream Injector Option Extream Injector Option 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 Voluson E8 Voluson E6 Optima CT660sPro Optima CT660 Optima CT660s Optima CT660Pro Console Generation Upgrade L2-9-D L8-18i-D ML6-15-D 6Tc-RS L2-9VN-D C1-6-D C3-10-D M5Sc-D C2-9-D LOGIQ E10 RAB6-D IC5-9-D RIC5-9-D C2-9VN-D P2D C1-6VN-D 4Vc-D 6S-D 8C 6Tc-RS 9T-RS iC5-9-D M5Sc-D 12S-D 6VT-D C2-9-D 9L-D P6D 11L-D P2D C1-6-D 9T Vivid E95 Vivid E90 C3-10-D 10T-D Vivid E80 L8-18i-D 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 RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT E8CS-RS L10-22-RS 4C-RS L6-12-RS RIC5-9A-RS C1-5-RS L8-18i-RS LOGIQ P9 8C-RS L4-12t-RS 12S-RS 9L-RS P6D LOGIQ P7 L12n-RS BE9CS-RS IC9-RS 3Sc-RS 6S-RS P2D L3-12-RS 6Tc-RS 12L-RS RAB2-6-RS ML6-15-RS 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 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 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 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 E8C-RS 12L-RS LK760-RS Versana Premier E8Cs-RS 6S-RS 8C-RS L6-12-RS RIC5-9A-RS 4C-RS L8-18i-RS RAB2-6-RS 3Sc-RS 12S-RS C1-5-RS 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 Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L Voluson E10 PA6-8-D RAM3-8 Voluson E8 Voluson E6 Probe 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 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 ASiR-V 9L t739 ERB 11L 12L 4C E8C 10L E8CS L4-12t-RS 4C-RS 8C-RS LK760-RS LOGIQ e NextGen C1-5-RS 9L-RS LOGIQ e 6Tc-RS E8C-RS 12L-RS 3Sc-RS 6S-RS L8-18i-RS L10-22-RS NextGen LOGIQ e ML6-15-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 12S-D 6VT-D L8-18i-D 4Vc-D IC5-9-D 6S-D C3-10-D P6D 11L-D M5Sc-D Vivid S70N Dimension C1-5-D 6Tc-RS ML6-15-D Vivid S70N C2-9-D P2D 9T-RS C1-6-D 9L-D 3Sc-RS Vivid S60N C1-6-D Probe 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 P6D 8C Vivid E95 11L-D C1-6-D L8-18i-D Vivid E80 9T C3-10-D 9T-RS C2-9-D 4V-D Vivid E90 M5Sc-D 6S-D 6Tc-RS P2D 9L-D iC5-9-D 12S-D 6VT-D Deep Learning Image Reconstruction 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 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 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 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 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 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 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 6S-RS E8Cs-RS L6-12-RS E8C-RS Versana Essential RAB2-6-RS 8C-RS 3Sc-RS LK760-RS 4C-RS 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 Venue 50 L8-18i-SC E8CS-SC 3S-SC 4C-SC L12n-SC 12L-SC 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 LOGIQ V5 4C-RS L6-12-RS 3Sc-RS RAB2-6-RS 12L-RS LOGIQ V5 Expert E8C-RS E8Cs-RS 8C-RS LOGIQ V3 6S-RS 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-12
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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-04-12
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-08-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-08-05
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
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	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
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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-12-16
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
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
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
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	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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-09-01
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
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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-09
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-26
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
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
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
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
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	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
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2004-09-24
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	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
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
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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-22
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
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
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
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
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-09-21
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
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-05
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	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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-11
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-01-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-01-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-01-02
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2017-10-24
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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-10-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-25
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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-02-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-02-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-02-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-08-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-01-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-01-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-01-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-11-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-11-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-11-07
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-05-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-09-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-09-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-09-26
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
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	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	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	2018-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-26
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	2012-09-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2012-09-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-09-25
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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-12-10
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-06-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-06-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-06-30
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-07-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-07-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-07-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-11-07
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-24
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	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
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	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	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	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
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
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
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	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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-08-09
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

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
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number	Establishment Name	Location
3042928350	Computer Vision AG	Wallisellen Zurich, CH
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3030088963	REBRAIN	PESSAC Gironde, FR
3042852277	REMEDY LOGIC	New York, NY, US
3027986210	MRIGUIDANCE B.V.	Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612283. Last updated year: 2026. Please use registration number 9612283 when referencing this establishment in official correspondence.