510(k) Report

FDA applicant

Philips Medical Systems Nederlands B.V.

Best, NL8 decisions2015–202411 recalls

FDA records 8 decisions for Philips Medical Systems Nederlands B.V. (Best, NL) from 2015 to 2024: 8 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 11 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 Nederlands B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12016: 22018: 22021: 12022: 12024: 1
2015high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2026

2018: 12021: 12022: 22023: 12024: 12025: 32026 (partial year): 2
2015high 3 (2025) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems Nederlands B.V. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Medical Systems Nederlands B.V.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging3decisions
  • OWBInterventional Fluoroscopic X-Ray System3decisions
  • LLZSystem, Image Processing, Radiological1decision
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 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.

  • K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 20222cite it
  • K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V. · 20161cites it

What has FDA decided for it lately?

  • K240224Zenition 90Philips Medical Systems Nederlands B.V. · 2024
  • K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 20225 recalls
  • K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V. · 2021
  • K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V. · 20182 recalls
  • K181966SmartPerfusionPhilips Medical Systems Nederlands B.V. · 20181 recall
  • K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V. · 2016
  • K153324Ingenia 1.5T and Ingenia 1.5T S R5.2Philips Medical Systems Nederlands B.V. · 20163 recalls
  • K143128mDIXON XDPhilips Medical Systems Nederlands B.V. · 2015

All 8 as Philips Medical Systems Nederlands B.V. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K223442MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software…Aug 28, 2026Class II
  • K193215MR 5300 Model Number (REF): 1. 782110, 2. 782152;Aug 21, 2026Class II
  • K213516Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and…Dec 3, 2025Class II
  • K212673MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;Jun 30, 2025Class II
  • K212673Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;May 13, 2025Class II
  • K181311Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that…May 2, 2024Class II