Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020021

FEI Number

3004377820

Entity Name

GE Healthcare Austria GmbH & Co OG

City/State/Country

ZIPF Oberosterreich, AT

Establishment Address

TIEFENBACH 15, ZIPF Oberosterreich 4871, AT

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

K201828

PMA Number

N/A

All Registered Proprietary Names

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 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 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L 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 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 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 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 Vscan Air Vscan Air SL Vscan Air CL 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 12L-RS E8C-RS 3Sc-RS RIC5-9A-RS RAB2-6-RS 4C-RS Voluson P6 Voluson P8 IC9-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 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 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 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 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 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 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 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 6S-RS E8Cs-RS L6-12-RS E8C-RS Versana Essential RAB2-6-RS 8C-RS 3Sc-RS LK760-RS 4C-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 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 Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L Voluson E10 PA6-8-D RAM3-8 Voluson E8 Voluson E6 Probe 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 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 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 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 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 Voluson P6 E8C-RS 12L-RS RAB2-6-RS 4C-RS 3Sc-RS Voluson P8 RIC5-9A-RS IC9-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 4D View Vscan Air CL Vscan Air 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 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 EchoPAC Connect EchoPAC Suite EchoPAC Plug-in EchoPAC EchoPAC Software Only 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 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 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 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 4D View 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 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 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 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	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
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
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	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
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
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	2023-09-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-09-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-09-21
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
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	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
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	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
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
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	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
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
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	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	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	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
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	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
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	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
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
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
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	2020-06-18
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-01-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-12-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-12-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-12-02
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	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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-07-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-21
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	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	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	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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-05-22
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
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	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
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

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
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020021. Last updated year: 2026. Please use registration number 8020021 when referencing this establishment in official correspondence.