510(k) Report

FDA applicant

AZmed

Paris, FR6 decisions2022–20260 recalls

FDA records 6 decisions for AZmed (Paris, FR) from 2022 to 2026: 6 510(k) clearances. Most are in product codes QBS (Radiological Computer Assisted…) and QFM (Radiological Computer-Assisted Prioritization…). Since 2016 its 510(k)s took a median of 102 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Azmed Sas”.

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

FDA decisions per year

2in 2025

2022: 12024: 12025: 22026 (partial year): 2
2022high 2 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — AZmed by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like AZmed’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?

  • QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture4decisions
  • QFMRadiological Computer-Assisted Prioritization Software For Lesions1decision
  • MYNAnalyzer, Medical Image1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 102 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240845RayvolveAzmed Sas · 20241cites it
  • K220164RayvolveAzmed Sas · 20221cites it
  • K260378RayvolveAZmed · 20261cites it

What has FDA decided for it lately?

All 4 as AZmed →All 2 as Azmed Sas →