Genius AI Detection 2.0— 510(k) K221449

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K221449 for Genius AI Detection 2.0, Substantially Equivalent on 2022-10-06. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2022-05-18
Decision date: 2022-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

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