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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

One record, written once. The elements below are the union of what the declared purposes ask for. Where a purpose is not declared, its elements are not shown and are not counted.

What this record answers
4 of 5 elements written, across 1 declared purpose.

Purposes declared

The purposes decide which elements are asked for. Text already written is kept when a purpose is dropped.

4 of 5 elements written

Elements

Each element states the purposes that ask for it. An element asked for by both purposes is written once.

Data protection impact assessment reference
Notified to the market surveillance authority on