ProFound AI Software V3.0— 510(k) K203822

Substantially Equivalent

Icad, Inc.

FDA 510(k) clearance K203822 for ProFound AI Software V3.0, Substantially Equivalent on 2021-03-12. Applicant: Icad, Inc..

Clearance details

Applicant: Icad, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2020-12-29
Decision date: 2021-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashua, NH, US

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