510(k) Report

FDA applicant

Philips Medical Systems MR Finland

Vantaa, FI4 decisions2008–20200 recalls

FDA records 4 decisions for Philips Medical Systems MR Finland (Vantaa, FI) from 2008 to 2020: 4 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is 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 MR Finland’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12016: 12019: 12020: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Philips Medical Systems MR Finland by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment3decisions
  • MOSCoil, Magnetic Resonance, Specialty1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 197 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 80 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K193109MRCAT brainPhilips Medical Systems MR Finland · 20202cite it
  • K151435MRCATPhilips Medical Systems MR Finland · 20161cites it
  • K182888MRCAT PelvisPhilips Medical Systems MR Finland · 20191cites it

What has FDA decided for it lately?

  • K193109MRCAT brainPhilips Medical Systems MR Finland · 2020
  • K182888MRCAT PelvisPhilips Medical Systems MR Finland · 2019
  • K151435MRCATPhilips Medical Systems MR Finland · 2016
  • K080120Hfo Shoulder CoilPhilips Medical Systems MR Finland · 2008

All 4 as Philips Medical Systems MR Finland →