MammoScreen— 510(k) K192854

Substantially Equivalent

Therapixel

FDA 510(k) clearance K192854 for MammoScreen, Substantially Equivalent on 2020-03-25. Applicant: Therapixel. Device class: 2.

Clearance details

Applicant: Therapixel
Product code: Code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2019-10-04
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valbonne, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDQ

K260898 — Transpara (2.1.0)2026-08-14
K260086 — CadAI-B Dx2026-08-12
K260303 — See-Mode Augmented Reporting Tool, Breast (SMART-B)2026-07-28
K260714 — MammoScreen® (5)2026-06-26
K253825 — Saige-Dx2026-06-15

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