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

Name: FDA 510(k) clearance DEN210035
Creator: U.S. Food and Drug Administration
Published: 2024-01-31

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.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code QYV
Device class: Class 2
Regulation: 21 CFR 864.3900
Advisory panel: Pathology
Date received: 2021-08-27
Decision date: 2024-01-31
Decision: Unknown
Clearance type: Direct
Location: Malborough, MA, US

View on FDA.gov ↗

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