DeviceClearance

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

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..

Clearance details

Applicant
Hologic, Inc.
Product code
Code QDQ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlborough, MA, US
Download summary PDFView on FDA.gov ↗

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