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
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 · 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
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Part 1
Description of modifications
List each specific, planned modification with its individual specification and the reason for it.
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Other records of this AI System
External Documents