SystemAIS-001Medical device and SaMD
Retinal Screening Assistant
Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.
Device class
Class IIa (MDR)
FDA
Class II, 510(k)
EU AI Act
High-risk (Annex I)
- Status
- Approved for operation
- State
- Deployed
- Owner
- Cirocco Jones
- Readiness
- 0
- Blockers
- 12
ISO/IEC 42001:2023
AI management system
Clauses and Annex A controls whose traceability can be carried by the records held here.
2 covered · 0 partial · 15 open
Working a clause
Select a clause on the left. Link the records that already carry the traceability, state how they address it, and attest it. A clause is only covered once someone attests.
Clauses
Left, the clause list. Right, the clause you are working.
6.1.2
AI risk assessment
Define and apply a process that identifies, analyses and evaluates AI risks, and retain the results.
Records of the kind this clause expects
Other records of this AI System
External Documents
Attested by Bron Helstrom on 2026-02-11.