Transpara 1.7.2— 510(k) K221347

Substantially Equivalent

Screenpoint Medical B.V.

FDA 510(k) clearance K221347 for Transpara 1.7.2, Substantially Equivalent on 2022-08-03. Applicant: Screenpoint Medical B.V..

Clearance details

Applicant: Screenpoint Medical B.V.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2022-05-09
Decision date: 2022-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nijmegen, NL

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