Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032350

FEI Number

3003309342

Entity Name

GE PARALLEL DESIGN, INC.

City/State/Country

PHOENIX, AZ, US

Establishment Address

4313 E COTTON CENTER BLVD STE 100, PHOENIX, AZ 85040, US

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

K202658

PMA Number

N/A

All Registered Proprietary Names

12L-RS E8C-RS 6S-RS 3Sc-RS Versana Balance 8C-RS E8Cs-RS L6-12-RS 4C-RS LK760-RS RAB2-6-RS 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 9L t739 ERB 11L 12L 4C E8C 10L E8CS 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 Invenia ABUS Workstation Invenia ABUS Invenia ABUS Scan Station Invenia ABUS Review Software ABUS Single-Use Stabilization Membrane - non Sterile Invenia ABUS 2 Invenia ABUS Prime Invenia ABUS Premium 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 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 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 12L-RS E8C-RS 3Sc-RS RIC5-9A-RS RAB2-6-RS 4C-RS Voluson P6 Voluson P8 IC9-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 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-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 6S-RS E8Cs-RS L6-12-RS E8C-RS Versana Essential RAB2-6-RS 8C-RS 3Sc-RS LK760-RS 4C-RS 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 RIC5-9-D RIC10-D L8-18i-D RM7C Voluson Expert 18 C1-6-D 6S-D ML6-15-D M5Sc-D 12S-D RSP6-16-D Voluson Expert 22 RAB6-D IC5-9-D Voluson Expert 20 C2-9-D RM6C eM6C G3 9L-D RIC6-12-D 11L-D 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 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 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 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 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 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 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 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 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 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 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 RIC5-9A-RS 3Sc-RS 12L-RS E8C-RS Voluson P8 IC9-RS Voluson P6 4C-RS IC9B-RS RAB2-6-RS 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 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 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 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 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 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 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 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 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 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 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 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 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 Voluson E8 Voluson E6 L4-20t-RS 3Sc-RS Vivid iq 6Tc-RS 6VT-D 12S-RS 9T-RS 6S-RS 8C-RS 4C-RS L8-18i-RS ML6-15-RS 9L-RS 10T-D P2D C1-5-RS M5Sc-RS 12L-RS E8Cs-RS 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 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 Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L Voluson E10 PA6-8-D RAM3-8 Voluson E8 Voluson E6 Probe 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 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 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 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 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 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 Invenia ABUS Viewer 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 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 C3-10-D BE9CS-RS ML6-15-RS P6D M5sc-RS L4-12t-RS 3Sc-RS L10-22-RS L3-12-RS 6S-RS C1-6-D 9L-RS LOGIQ P8 E8CS-RS IC9-RS RAB2-6-RS C1-5-RS 12L-RS L8-18i-RS L6-12-RS 12S-RS 8C-RS E8C-RS RIC5-9A-RS LOGIQ P10 LOGIQ P9 6Tc-RS P2D 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 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 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 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 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 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 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 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 Voluson P6 E8C-RS 12L-RS RAB2-6-RS 4C-RS 3Sc-RS Voluson P8 RIC5-9A-RS IC9-RS 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 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 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 Voluson Performance 18 RAB2-6-RS 9L-RS RAB6-RS 4C-RS 3Sc-RS IC9-RS IC9B-RS RIC5-9A-RS 12L-RS 12S-RS C1-5-RS Voluson Performance 16 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 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 6S 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 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 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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	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	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
PAA	Automated Breast Ultrasound	Unknown	Class 3	N/A	2013-02-11
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	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
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	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
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	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
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	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
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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-07
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	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
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
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
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	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	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
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	2020-11-16
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	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	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
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
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	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	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	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	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
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
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
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	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
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
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	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
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	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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	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	2022-08-05
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	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
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
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
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	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	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
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
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-13
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
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-01-12
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
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
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
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	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
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	2023-06-22
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
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
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
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
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
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	2025-06-02
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-02
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	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	2010-06-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-06-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-06-03
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
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
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
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

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
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
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

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
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3025786376	ACO HEALTHCARE CO., LTD.	Taoyuan City, TW
3004752776	Compumedics Germany GmbH	Singen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032350. Last updated year: 2026. Please use registration number 2032350 when referencing this establishment in official correspondence.