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, 5 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3012563754) in Best Noord-Brabant, Netherlands. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated March 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012563754
- Address
- Veenpluis 6, Best Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 3, 2019
- Registered through
- 2026
- Brand names listed
- Philips IntelliSite Pathology Solution, Philips IntelliSite Pathology Solution 5.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Whole Slide Imaging System | PSY | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 6, 2025 | K243871 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 10, 2024 | K242848 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 2, 2024 | K241871 | Philips IntelliSite Pathology Solution | PSY | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 24, 2024 | K233204 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| September 20, 2019 | K192259 | Philips IntelliSite Pathology Solution | PSY | Substantially Equivalent | Philips Electronics Nederland B.V. | accessdata.fda.gov |
Compare with other makers
Updated March 6, 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.