MammoScreen® (4)— 510(k) K243679

Substantially Equivalent

Therapixel

FDA 510(k) clearance K243679 for MammoScreen® (4), Substantially Equivalent on 2025-07-03. Applicant: Therapixel.

Clearance details

Applicant: Therapixel
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

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