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Philips Medical Systems Technologies Ltd.: FDA-registered device maker in Haifa, Israel, 23 510(k) clearances

Name: Philips Medical Systems Technologies Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Medical Systems Technologies Ltd. is registered with the FDA (registration 9617978) in Haifa, Israel. It lists 4 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 27, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617978
FEI number: 3008581796
Address: Advanced Technology Center Matam Building 34, Haifa, Israel, 3100202
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: November 21, 2007
Registered through: 2026
Brand names listed: BrightView XCT SPECT/CT Imaging System, Briliance 64, Brilliance 16, Brilliance 16 Power CT Systems, Brilliance 6, Brilliance 64, Brilliance CT Big Bore, CT 5300 and more

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Contract manufacturer, 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
May 27, 2026	K260207	Multimodality Simulation Workspace (MM Sim) (v1.0.0)	MUJ	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
March 27, 2026	K253649	Spectral CT Verida Family	JAK	Substantially Equivalent	Philips Medical Systems Technologies , Ltd.	accessdata.fda.gov
June 27, 2025	K250648	Philips iCT CT system	JAK	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 16, 2025	K244008	Spectral CT	JAK	Substantially Equivalent	Philips Medical Systems Technologies , Ltd.	accessdata.fda.gov
October 18, 2024	K240844	Spectral CT 7500 RT	JAK	Substantially Equivalent	Philips Medical Systems Technologies , Ltd.	accessdata.fda.gov
May 13, 2022	K212875	Spectral CT on Rails	JAK	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
August 6, 2021	K211764	Vereos PET/CT	KPS	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 19, 2021	K210880	Vereos PET/CT	KPS	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
January 24, 2020	K193454	IQon Spectral CT	JAK	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
November 9, 2017	K171850	Philips CT Big Bore	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
October 6, 2017	K172406	Ingenuity TF	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
June 23, 2009	K090462	BRILLIANCE DUAL ENERGY OPTION	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
April 29, 2008	K081135	GEMINI CONDOR	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
April 11, 2008	K080927	BRIGHTVIEW VCT IMAGING SYSTEM	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
May 1, 2006	K061029	JETSTREAM WORKSPACE	LLZ	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
October 7, 2005	K052640	GEMINI RAPTOR	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
May 23, 2005	K051170	GEMINI GXL	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
September 8, 2004	K042293	BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
July 29, 2004	K041955	GEMINI PET/CT IMAGING SYSTEM	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
October 29, 2003	K033326	PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM	JAK	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov
October 22, 2003	K033254	FORTE GAMMA CAMERA SYSTEM	KPS	Substantially Equivalent	Adac Laboratories	accessdata.fda.gov
September 13, 2001	K012009	MX8000 IDT CT SYSTEM	JAK	Substantially Equivalent	Marconi Medical Systems, Inc.	accessdata.fda.gov

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Updated May 27, 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.