510(k) Report

FDA applicant

Planmed OY

Helsinki, FI20 decisions1992–20250 recalls

FDA records 20 decisions for Planmed OY (Helsinki, FI) from 1992 to 2025: 20 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and MUE (Full Field Digital, System, X-Ray, Mammographic). Since 2016 its 510(k)s took a median of 395 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 12 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 Planmed OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12013: 12015: 12017: 12018: 12020: 12022: 22025: 1
2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Planmed OY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic11decisions
  • MUEFull Field Digital, System, X-Ray, Mammographic4decisions
  • OASX-Ray, Tomography, Computed, Dental3decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • SFVX-Ray, Computed Tomography, Cone-Beam1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 395 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 12 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.

  • K163328Planmed ClarityPlanmed OY · 20172cite it
  • K180918Planmed VerityPlanmed OY · 20181cites it
  • K983659Planmed Sophie & Planned Sophie ClassicPlanmed OY · 19981cites it
  • K143435Planmed VerityPlanmed OY · 20151cites it
  • K013656Planmed Sophie & Planmed Sophie ClassicPlanmed OY · 20021cites it
  • K121418Planmed VerityPlanmed OY · 20131cites it

What has FDA decided for it lately?

  • K250318Planmed XFIPlanmed OY · 2025
  • K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022
  • K213278Planmed VerityPlanmed OY · 2022
  • K192317Planmed Clarity 2D and Clarity SPlanmed OY · 2020
  • K180918Planmed VerityPlanmed OY · 2018
  • K163328Planmed ClarityPlanmed OY · 2017
  • K143435Planmed VerityPlanmed OY · 2015
  • K121418Planmed VerityPlanmed OY · 2013

All 20 as Planmed OY →