Data / Medical devices / Netherlands / Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.: FDA-registered device maker in Best Noord-Brabant, Netherlands, 23 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3015777306) in Best Noord-Brabant, Netherlands. It lists 4 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 27, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015777306
- Address
- Veenpluis 6, Best Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Specification developer
- 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, Dual Energy Option for Brilliance iCT Ctsystem and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Specification developer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 28, 2025 | 96423 | Class II | Ongoing | Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334 | Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
- All makers of System, Planning, Radiation Therapy Treatment
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.