510(k) Report

FDA applicant

Combinostics OY

Tampere, FI3 decisions2018–20240 recalls

FDA records 3 decisions for Combinostics OY (Tampere, FI) from 2018 to 2024: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPS (System, Tomography, Computed, Emission). Since 2016 its 510(k)s took a median of 202 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Combinostics OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12023: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Combinostics OY by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions
  • KPSSystem, Tomography, Computed, Emission1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 202 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 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K171328cNeuro cMRICombinostics OY · 20181cites it
  • K231576cNeuro cPETCombinostics OY · 20231cites it

What has FDA decided for it lately?

  • K233908cNeuro cDATCombinostics OY · 2024
  • K231576cNeuro cPETCombinostics OY · 2023
  • K171328cNeuro cMRICombinostics OY · 2018

All 3 as Combinostics OY →