510(k) Report

FDA applicant

Avatar Medical

Paris, FR4 decisions2023–20260 recalls

FDA records 4 decisions for Avatar Medical (Paris, FR) from 2023 to 2026: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Avatar Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2023: 12025: 22026 (partial year): 1
2023high 2 (2025) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Avatar Medical by year, 2023–2026Sources: 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, Radiological3decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 154 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K222035Avatar Medical Software V1Avatar Medical · 20232cite it

What has FDA decided for it lately?

  • K253950Avatar Medical VisionAvatar Medical · 2026
  • K252665brAIn™ Shoulder PositioningAvatar Medical · 2025
  • K243292brAIn™ Shoulder PositioningAvatar Medical · 2025
  • K222035Avatar Medical Software V1Avatar Medical · 2023

All 4 as Avatar Medical →