Genius Digital Diagnostics System with the Genius Cervical AI algorithm— 510(k) DEN210035

Unknown

Hologic, Inc.

FDA 510(k) clearance DEN210035 for Genius Digital Diagnostics System with the Genius Cervical AI algorithm, Unknown on 2024-01-31. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code QYV
Advisory panel: Pathology
Date received: 2021-08-27
Decision date: 2024-01-31
Decision: Unknown
Clearance type: Direct
Location: Malborough, MA, US

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