510(k) Report

FDA applicant

Philips Medical Systems Nethrlands BV

Best Noord-Brabant, NL5 decisions2014–201611 recalls

FDA records 5 decisions for Philips Medical Systems Nethrlands BV (Best Noord-Brabant, NL) from 2014 to 2016: 5 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 5 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Philips Medical Systems Nethrlands BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12015: 32016: 1
2014high 3 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

3in 2025

2016: 12017: 12019: 12021: 32023: 12024: 12025: 3
2014high 3 (2021) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems Nethrlands BV by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System2decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • LLZSystem, Image Processing, Radiological1decision
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142708Veradius UnityPhilips Medical Systems Nethrlands BV · 20143cite it
  • K153022Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV · 20152cite it
  • K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 20151cites it
  • K162148Allura Xper R9Philips Medical Systems Nethrlands BV · 20161cites it
  • K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV · 20151cites it

What has FDA decided for it lately?

  • K162148Allura Xper R9Philips Medical Systems Nethrlands BV · 20163 recalls
  • K153022Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV · 20153 recalls
  • K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 20151 recall
  • K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015
  • K142708Veradius UnityPhilips Medical Systems Nethrlands BV · 20144 recalls

All 5 as Philips Medical Systems Nethrlands BV →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K153022IntelliSpace Cardiovascular, Software 8.0.0.4.Aug 8, 2025Class II
  • K153022IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.Apr 7, 2025Class II
  • K142708Veradius Unity. Product Code 718132. The devices are used for radiological guidance and…Feb 25, 2025Class II
  • K153022Philips IntelliSpace Cardiovascular software, Model 830089.Apr 4, 2024Class II
  • K142708Veradius Unity Mobile Surgery C-armOct 4, 2023Class II
  • K142708Veradius Unity, Model #718132Dec 2, 2021Class II