K243341
- 510(k) number
- K243341
- Device name
- Genius AI Detection 2.0
- Applicant
- Hologic, Inc. DE · US
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2025-07-31
- Date received
- 2024-10-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243341.pdf
Official FDA record: K243341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.