Allix5
FDA 510(k) clearance DEN240047 · decided 2025-05-30
Clearance details
- K-number
- DEN240047
- Device name
- Allix5
- Applicant
- Clairity, Inc.
- Decision
- Unknown
- Date received
- 2024-09-06
- Decision date
- 2025-05-30
- Days to decision
- 266 days
- Clearance type
- Direct
- Product code
- SEZ
- Device class
- 2
- Regulation number
- 892.8500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.