Data / Medical devices / Israel / Ge Medical Systems Israel, Functional Imaging

Ge Medical Systems Israel, Functional Imaging: FDA-registered device maker in TIRAT HACARMEL Haifa, Israel, 37 510(k) clearances

Name: Ge Medical Systems Israel, Functional Imaging FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ge Medical Systems Israel, Functional Imaging is registered with the FDA (registration 9613299) in TIRAT HACARMEL Haifa, Israel. It lists 8 device types. The FDA files 37 510(k) clearances under its listings, the newest dated June 12, 2025. 5 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Ge Medical Systems Israel, Functional Imaging

FDA registration number: 9613299
FEI number: 3004571294
Address: 4 Hayozma ST., TIRAT HACARMEL Haifa, Israel, 30200
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Specification developer
First device listed: April 6, 1994
Registered through: 2027
Brand names listed: Aurora, Brivo NM 615, Clarify DL, D670 HEAD HOLDER, DaTQUANT, Discovery 670 DR, Discovery Future, Discovery IQ and more

Devices it lists

Device	Product code	Class	Role	Source
Bed, Scanning, Nuclear	IYZ	1	Manufacturer	accessdata.fda.gov
Camera, Scintillation (Gamma)	IYX	1	Manufacturer	accessdata.fda.gov
Cradle, Patient, Radiologic	KXH	1	Manufacturer	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer, Specification developer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer, Specification developer	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 12, 2025	K251153	Aurora	KPS	Substantially Equivalent	Ge Medical Systems Israel	accessdata.fda.gov
January 17, 2025	K243605	Aurora	KPS	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging	accessdata.fda.gov
January 3, 2025	K241350	Clarify DL	LLZ	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging	accessdata.fda.gov
August 8, 2024	K241665	Omni Legend	KPS	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging	accessdata.fda.gov
April 27, 2023	K223212	Precision DL	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
March 1, 2023	K221680	Xeleris V Processing and Review System	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 2, 2022	K221932	Omni Legend	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 27, 2021	K212004	MyoSPECT, MyoSpect ES	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 20, 2021	K211846	Discovery MI Gen2	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 29, 2021	K210173	StarGuide	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 25, 2020	K201103	Xeleris V Processing and Review Systems	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
April 17, 2018	K173816	NM/CT 850, NM/CT 860	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
April 11, 2018	K180318	PET Digital Gating	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 18, 2016	K160933	Discovery NM 750b Bopsy	IYX	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 11, 2016	K161574	Discovery MI	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 16, 2016	K153355	Xeleris 4.0 Processing and Review Workstation	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 21, 2016	K153402	Discovery NM/CT 670 CZT	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 14, 2015	K151372	Low Dose CT Lung Cancer Screening Option for Qualified GE Systems	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 18, 2014	K141477	DISCOVERY IQ	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 21, 2014	K133657	DISCOVERY PET/CT 710	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 12, 2013	K130884	XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION	LLZ	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
April 19, 2012	K121019	OPTIMA NM/CT 640	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
December 5, 2011	K113350	BRIVO NM 615	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
June 3, 2011	K111445	DISCOVERY NM 630	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
November 3, 2010	K102231	DISCOVERY NM 750B	IYX	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging	accessdata.fda.gov
January 8, 2010	K093982	XELERIS 3 PROCESSING AND REVIEW WORKSTATION	LLZ	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
December 10, 2009	K093514	DISCOVERY MODEL NM/CT 670	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
December 12, 2008	K083504	GE DISCOVERY NM/CT 570C	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
January 31, 2008	K080124	VENTRI 1.1	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
September 27, 2005	K052434	HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA	KPS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
August 2, 2005	K051855	VENTRI	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
July 18, 2005	K051673	XELERIS 2 PROCESSING AND REVIEW WORKSTATION	LLZ	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
January 15, 2003	K024137	JUPITER PROCESSING AND REVIEW WORKSTATION	LLZ	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
September 19, 2002	K022960	GE QUASAR NUCLEAR MEDICINE SYSTEM	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
August 23, 1999	K991896	MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
October 10, 1996	K962738	MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS	KPS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
July 3, 1995	K951144	PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS	KPS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 10, 2025	98133	Class II	Ongoing	SMV DSX New Line, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detec	accessdata.fda.gov
June 20, 2025	97193	Class II	Ongoing	Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system	Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.	accessdata.fda.gov
December 18, 2024	96079	Class II	Ongoing	GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mountin	accessdata.fda.gov
April 15, 2024	94557	Class II	Ongoing	MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).	There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.	accessdata.fda.gov
December 19, 2022	91456	Class I	Ongoing	GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry	A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.	accessdata.fda.gov

Compare with other makers

Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.