DEN240047
- 510(k) number
- DEN240047
- Device name
- Allix5
- Applicant
- Clairity, Inc. TX · US
- Product code
- SEZ — Radiological Software Device To Predict Future Breas
- Decision date
- 2025-05-30
- Date received
- 2024-09-06
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN240047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.