510(k) clearance
Artificial Intelligence Renal Assessment (AIRA) Version 1
- 510(k) number
- K261677
- Applicant
- Aramis Global AI Consultancies, LLC
- Decision date
- Sep 15, 2026
- Date received
- May 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QIH
- Device type
- Automated Radiological Image Processing Software
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Dubai, AE