510(k) Report

FDA applicant

Thirona BV

Nijmegen, NL3 decisions2018–20250 recalls

FDA records 3 decisions for Thirona BV (Nijmegen, NL) from 2018 to 2025: 3 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Thirona Corporation”.

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 Thirona BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12024: 12025: 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 — Thirona BV 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?

  • JAKSystem, X-Ray, Tomography, Computed3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 169 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K173821LungQ SoftwareThirona Corporation · 20182cite it
  • K232412LungQ v3.0.0Thirona BV · 20241cites it

What has FDA decided for it lately?

  • K250766LungQ 4Thirona BV · 2025
  • K232412LungQ v3.0.0Thirona BV · 2024
  • K173821LungQ SoftwareThirona Corporation · 2018

All 2 as Thirona BV →The one decision as Thirona Corporation →