510(k) Report

FDA applicant

Philips Medical Systems Netherland BV

Best, NL1 decision2014–201481 recalls

FDA records 1 decision for Philips Medical Systems Netherland BV (Best, NL) in 2014: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 1 predicate, 0 of them its own earlier devices. 81 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 Netherland BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

6in 2026

2015: 162016: 32017: 22018: 72019: 32021: 52022: 12023: 12024: 42025: 332026 (partial year): 6
2014high 33 (2025) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems Netherland 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 System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 20143cite it

What has FDA decided for it lately?

  • K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 201481 recalls

The one decision as Philips Medical Systems Netherland BV →

What has been recalled?

81 recalls linked to its devices; the latest:

  • K161563Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039…Jun 29, 2026Class II
  • K102005Philips Allura under the following System Descriptions and corresponding model numbers…Jun 17, 2026Class II
  • K102005Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional…Jun 17, 2026Class II
  • K102005Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper…May 18, 2026Class II
  • K102005Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003…Apr 30, 2026Class II
  • K102005Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221)…Apr 30, 2026Class II