Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015777306

FEI Number

3015777306

Entity Name

Philips Medical Systems Nederland B.V.

City/State/Country

Best Noord-Brabant, NL

Establishment Address

Veenpluis 6, Best Noord-Brabant 5684 PC, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K033326

PMA Number

N/A

All Registered Proprietary Names

Spectral CT 7500 RT GEMINI 16 PET/CT Imaging Systems BrightView BrightView X SPECT Imaging Systems Philips iCT CT System NM Application Suite Spectral CT on Rails Spectral CT 728351Multimodality Simulation Workspace (MM Sim) 1 Upgrade 728349 Multimodality Simulation Workspace (MM Sim) 1 JETStream Workspace Brilliance CT Big Bore Philips CT Big Bore GEMINI TF Big Bore PET/CT Imaging System Upgrade Spectral CT Verida RT Spectral CT Verida Upgrade Spectral CT Verida Upgrades Spectral CT 7500 RT SW5.4 Spectral CT Verida RT Upgrade Spectral CT 7500 SW5.4 Dual Energy Option for Brilliance iCT Ctsystem GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 Ingenuity TF Ingenuity Flex Brilliance 64

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	2024-11-06
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
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2007-11-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2009-05-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-05-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-23
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-06-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-11-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-11-27
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2009-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-04-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-03-01
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
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-06-16

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
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015777306. Last updated year: 2026. Please use registration number 3015777306 when referencing this establishment in official correspondence.