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GE Medical Systems Israel, Functional Imaging: FDA-registered device maker in Haifa, Israel, 11 510(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 3033524251) in Haifa, Israel. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 12, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3033524251
Address: Ha Peles 18, Haifa, Israel, 26289
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer
First device listed: June 16, 2010
Registered through: 2027
Brand names listed: Aurora, D670 HEAD HOLDER, Discovery 670 DR, Discovery NM 630, Discovery NM/CT 670, Discovery NM/CT 670 CZT, Discovery NM/CT 670 ES, Discovery NM/CT 670 Pro and more

Devices it lists

Device	Product code	Class	Role	Source
Cradle, Patient, Radiologic	KXH	1	Manufacturer	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	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
August 8, 2024	K241665	Omni Legend	KPS	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging	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
March 29, 2021	K210173	StarGuide	KPS	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
January 21, 2016	K153402	Discovery NM/CT 670 CZT	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
April 19, 2012	K121019	OPTIMA NM/CT 640	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
June 3, 2011	K111445	DISCOVERY NM 630	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
December 10, 2009	K093514	DISCOVERY MODEL NM/CT 670	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov

Compare with other makers

Updated June 12, 2025. 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.