510(k) DEN240047
- Device
- Allix5
- Applicant
- Clairity, Inc.
- 510(k) number
- DEN240047
- Product code
- SEZ
- Decision
- Unknown (DENG)
- Decision date
- 2025-05-30
- Date received
- 2024-09-06
- Regulation
- 892.8500
- Classification name
- Radiological Software Device To Predict Future Breast Cancer Risk
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kris Zeschin
- Address
- 201 W 5th St., Suite 1500 Austin TX US 78701 78701
FDA Registration Numbers
- 3042248140
Source Documents
510(k) summary PDF not indicated by FDA