Genius AI Detection 2.0
FDA 510(k) clearance K221449 · decided 2022-10-06
Clearance details
- K-number
- K221449
- Device name
- Genius AI Detection 2.0
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-18
- Decision date
- 2022-10-06
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- QDQ
- Device class
- 2
- Regulation number
- 892.2090
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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