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
Coverage records where a requirement is addressed by the records this AI System already holds. It does not state that the AI System is compliant.
What to monitor
5 standards monitored, 41 clauses with nothing linked.
Standards
Select the standards this AI System is monitored against. Only the selected ones are assessed.
ISO/IEC 42001:2023
AI management system
Clauses and Annex A controls whose traceability can be carried by the records held here.
ISO/IEC 23894:2023
Guidance on AI risk management
The risk management process, traced to AI Risks and the reviews that accept them.
ISO/IEC 23053:2022
Framework for AI systems using machine learning
The machine learning pipeline, traced to datasets, model versions and monitoring.
EN 18286:2026
Quality management system for EU AI Act regulatory purposes
AI system realization, operations and change clauses that the records can evidence.