Visage Breast Density— 510(k) K201411

Substantially Equivalent

Visage Imaging GmbH

FDA 510(k) clearance K201411 for Visage Breast Density, Substantially Equivalent on 2021-01-29. Applicant: Visage Imaging GmbH.

Clearance details

Applicant: Visage Imaging GmbH
Product code: Code QIH
Advisory panel: Radiology
Date received: 2020-05-28
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

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