510(k) Report

FDA applicant

Therapixel

Nice, FR7 decisions2020–20260 recalls

FDA records 7 decisions for Therapixel (Nice, FR) from 2020 to 2026: 7 510(k) clearances. Most are in product codes QDQ (Radiological Computer Assisted…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 182 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 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 Therapixel’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 12021: 12024: 22025: 22026 (partial year): 1
2020high 2 (2024) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Therapixel by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…5decisions
  • QIHAutomated Radiological Image Processing Software2decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 182 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 7 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 5 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.

  • K192854MammoScreenTherapixel · 20201cites it
  • K240301MammoScreen® (3)Therapixel · 20241cites it
  • K211541MammoScreen 2.0Therapixel · 20211cites it
  • K241561MammoScreen BDTherapixel · 20241cites it
  • K243679MammoScreen® (4)Therapixel · 20251cites it

What has FDA decided for it lately?

  • K260714MammoScreen® (5)Therapixel · 2026
  • K243685MammoScreen BDTherapixel · 2025
  • K243679MammoScreen® (4)Therapixel · 2025
  • K241561MammoScreen BDTherapixel · 2024
  • K240301MammoScreen® (3)Therapixel · 2024
  • K211541MammoScreen 2.0Therapixel · 2021
  • K192854MammoScreenTherapixel · 2020

All 7 as Therapixel →