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 23894:2023
Guidance on AI risk management
The risk management process, traced to AI Risks and the reviews that accept them.
0 covered · 0 partial · 7 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.
6.4.2
Risk identification
Identify risks arising from the AI system, including its data and its use context.
Nothing is linked to 6.4.2. Link the Risk record that addresses it and state how.
Records of the kind this clause expects
Other records of this AI System
External Documents