MammoScreen— 510(k) K192854

Substantially Equivalent

Therapixel

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

Clearance details

Applicant: Therapixel
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2019-10-04
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valbonne, FR

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