Genius AI Detection 2.0 with CC-MLO Correlation— 510(k) K230096

Name: FDA 510(k) clearance K230096
Creator: U.S. Food and Drug Administration
Published: 2023-05-23

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K230096 for Genius AI Detection 2.0 with CC-MLO Correlation, Substantially Equivalent on 2023-05-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2023-01-13
Decision date: 2023-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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