Genius AI Detection 2.0— 510(k) K243341
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K243341 for Genius AI Detection 2.0, Substantially Equivalent on 2025-07-31. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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