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..
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code QDQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.