Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617978

FEI Number

3008581796

Entity Name

PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

City/State/Country

HAIFA, IL

Establishment Address

ADVANCED TECHNOLOGY CENTER, MATAM BUILDING 34, HAIFA 3100202, IL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062298

PMA Number

N/A

All Registered Proprietary Names

Incisive CT Spectral CT on Rails GEMINI 16 PET/CT Imaging Systems Dual Energy Option for Brilliance iCT Ctsystem Vereos PET/CT GEMINI TF Big Bore PET/CT Imaging System Brilliance CT Big Bore Philips CT Big Bore Ingenuity Core Ingenuity Core 128 CT Systems Ingenuity Spectral CT 7500 RT Philips iCT CT System Ingenuity TF NM Application Suite Brilliance 16 Brilliance 16 Power CT Systems Brilliance 6 GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 IQon Spectral CT CT Rembra CT Areta RT CT Rembra RT JETPack 2 CT 5300 JETStream Workspace Ingenuity Flex Brilliance 64 Vereos PET/CT BrightView BrightView X SPECT Imaging Systems

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	2022-04-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-05-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-03-01
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-08-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-08-04
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-11-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-08-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-11-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-02
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-10-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-10-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2009-05-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-06-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-01-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-03-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-11-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-11-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-06-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-06-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-06-02
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2007-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Pedroza Business: Philips Email: martin.pedroza@philips.com Phone: (440) 2197243

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

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 9617978. Last updated year: 2026. Please use registration number 9617978 when referencing this establishment in official correspondence.