Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Therapixel with 7 510(k) clearances and 7 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 26, 2026: MammoScreen® (5).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 26, 2026 | MammoScreen® (5)K260714 · QDQ | 510(k) clearances |
| Jun 26, 2026 | MammoScreen® (5)K260714 · Radiology | AI-enabled devices |
| Aug 22, 2025 | MammoScreen BDK243685 · QIH | 510(k) clearances |
| Aug 22, 2025 | MammoScreen BDK243685 · Radiology | AI-enabled devices |
| Jul 3, 2025 | MammoScreen® (4)K243679 · QDQ | 510(k) clearances |
| Jul 3, 2025 | MammoScreen® (4)K243679 · Radiology | AI-enabled devices |
| Oct 2, 2024 | MammoScreen BDK241561 · QIH | 510(k) clearances |
| Oct 2, 2024 | MammoScreen BDK241561 · Radiology | AI-enabled devices |
| Aug 1, 2024 | MammoScreen® (3)K240301 · QDQ | 510(k) clearances |
| Aug 1, 2024 | MammoScreen® (3)K240301 · Radiology | AI-enabled devices |
| Nov 26, 2021 | MammoScreen 2.0K211541 · QDQ | 510(k) clearances |
| Nov 26, 2021 | MammoScreen 2.0K211541 · Radiology | AI-enabled devices |
| Mar 25, 2020 | MammoScreenK192854 · QDQ | 510(k) clearances |
| Mar 25, 2020 | MammoScreenK192854 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
