MammoScreen BD— 510(k) K243685

Substantially Equivalent

Therapixel

FDA 510(k) clearance K243685 for MammoScreen BD, Substantially Equivalent on 2025-08-22. Applicant: Therapixel. Device class: 2.

Clearance details

Applicant: Therapixel
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.