GE Medical Systems, Israel Ltd.

FDA Device Registration & Listing · Haifa, IL · Registration 9615849

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615849
FEI Number
3002973981
Entity Name
GE Medical Systems, Israel Ltd.
City/State/Country
Haifa, IL
Establishment Address
Nativ Ha'or Street no. 1, Haifa 3508510, IL
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
GE HealthCare Technologies Inc. (Owner Number: 9912004)
Owner / Operator Contact Address
3000 N. Grandview Blvd, Waukesha, WI 53188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203137
PMA Number
N/A

All Registered Proprietary Names

L4-20t-RS L10-22-RS 9L-RS Venue Go 8C-RS E8C-RS L8-18i-RS 3Sc-RS 6S-RS ML6-15-RS L4-12t-RS M5Sc-RS 12L-RS 6Tc-RS 12S-RS C1-5-RS 12L-RS L10-22-RS ML6-15-RS 12S-RS L8-18i-RS 8C-RS L4-20t-RS C1-5-RS 3Sc-RS Venue Fit M5Sc-RS 9L-RS L4-12t-RS 6Tc-RS 6S-RS E8C-RS L4-12t-RS ML6-15-RS 12S-RS M5Sc-RS Venue L4-20t-RS 3Sc-RS L12n-RS 6S-RS L10-22-RS 8C-RS 12L-RS C1-5-RS C2-9-RS L8-18i-RS 6Tc-RS E8C-RS 9L-RS 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 Venue Sprint 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 L12n-RS C1-5-RS 8C-RS 12L-RS E8C-RS 3Sc-RS 9L-RS Venue 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 12L-RS Venue 6Tc-RS 9L-RS C1-5-RS E8C-RS 8C-RS L8-18i-RS 3Sc-RS L12n-RS L4-12t-RS 6S-RS 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 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

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 2022-06-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-22
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
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
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 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 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 2018-05-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 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 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

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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615849. Last updated year: 2026. Please use registration number 9615849 when referencing this establishment in official correspondence.
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