MammoScreen 2.0— 510(k) K211541

Substantially Equivalent

Therapixel

FDA 510(k) clearance K211541 for MammoScreen 2.0, Substantially Equivalent on 2021-11-26. Applicant: Therapixel.

Clearance details

Applicant: Therapixel
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2021-05-19
Decision date: 2021-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

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