MammoScreen BD— 510(k) K243685

Substantially Equivalent

Therapixel

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

Clearance details

Applicant: Therapixel
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

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