Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033524251

FEI Number

3033524251

Entity Name

GE Medical Systems Israel, Functional Imaging

City/State/Country

Haifa, IL

Establishment Address

Ha Peles 18, Haifa 26289, IL

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

K111445

PMA Number

N/A

All Registered Proprietary Names

Aurora StarGuide StarGuide Plus NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Discovery NM/CT 670 CZT NM/CT 870 CZT NM 830 Discovery NM 630

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-02-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-05-04
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-05-04
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-04-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-04-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2010-06-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-02-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-02-29
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2011-07-07

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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033524251. Last updated year: 2026. Please use registration number 3033524251 when referencing this establishment in official correspondence.