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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

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
6 standards monitored, 55 clauses with nothing linked.

Standards

Select the standards this AI System is monitored against. Only the selected ones are assessed.

Regulation (EU) 2024/1689
EU AI Act

Only the articles this AI System's classification engages, filtered by the roles it holds. Monitored automatically while the Act applies.

Required by law. The classification of this AI System engages this instrument, so it is monitored and cannot be switched off.

0% covered · 14 clauses
ISO/IEC 42001:2023
AI management system

Clauses and Annex A controls whose traceability can be carried by the records held here.

12% covered · 17 clauses
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 · 7 clauses
ISO/IEC 23053:2022
Framework for AI systems using machine learning

The machine learning pipeline, traced to datasets, model versions and monitoring.

0% covered · 6 clauses
EN 18286:2026
Quality management system for EU AI Act regulatory purposes

AI system realization, operations and change clauses that the records can evidence.

0% covered · 10 clauses
FDA PCCP guidance
Predetermined change control plan for AI-enabled device software functions

The three required parts of a PCCP in a marketing submission.

0% covered · 6 clauses