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
- In operation
- State
- Deployed
- Owner
- Cirocco Jones
- Record completeness
- 0
100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.
The system is in operation while its record stands below the floor of 70. That contradiction is raised as blocker STATE-01.
- Blockers
- 14
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 carry the traceability, state how they address it, and attest it. A clause is covered once it is attested.
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
Evidence
One reference for this clause. Link evidence already held, or register it here with its location or file.
DHF-2291-RMR-003Risk management report
Attested by Bron Helstrom on 2026-02-11.