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 23053:2022
Framework for AI systems using machine learning
The machine learning pipeline, traced to datasets, model versions and monitoring.
0 covered · 1 partial · 5 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.
8.2
Data acquisition
State the source, the collection method and the coverage of the data acquired.
Nothing is linked to 8.2. Link the Dataset or Data version record that addresses it and state how.
Records of the kind this clause expects
Other records of this AI System
External Documents