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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
ISO/IEC 23894:2023

Guidance on AI risk management

The risk management process, traced to AI Risks and the reviews that accept them.

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All standards
0 covered · 0 partial · 7 open
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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

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6.4.2

Risk identification

Open

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
Evidence

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