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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

An External Document is a record like any other. Attach the file, or give the location where the document is held, a document library, a drive, a repository. Aims Dog keeps the reference, the version and the effective date, so a clause can be traced to it and the trace survives a new version.

Documents held here
3 documents registered against this AI System.

Registered documents

Most recently effective first.

DocumentDOC-003

Post-market surveillance plan

Reference
DocumentDHF-2291-PMS-001
Type
Plan
Version
1.4
Effective
2025-11-12
Held at
pms-plan.pdf
Clauses
0
Monitoring of field performance, complaints and drift after release.
DocumentDOC-001

AI management system manual

Reference
DocumentQMS-AIMS-MAN-001
Type
Manual
Version
3.0
Effective
2025-06-01
Held at
aims-manual-v3.pdf
Clauses
1
Scope, context and management commitment of the AI management system.
DocumentDOC-002

Data governance procedure

Reference
DocumentQMS-DAT-PRO-014
Type
Procedure
Version
2.1
Effective
2024-09-18
Held at
data-governance-procedure.pdf
Clauses
1
Acquisition, labelling, provenance and retention of training and test data.

Register a document

It becomes a record of kind External Document.

File, if you hold one here

Nothing attached. A location is enough on its own.

A title and a reference are needed before the record can be created.