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
Connected repository
One connection per AI System. Model versions carry the commit that produced them.
Provider
GitHub
Repository
Default branch
main
Connected on
2024-03-06
Last sync
2026-07-29
Open events
2
What the repository is telling us
2 events have no governance response. Change is happening in the repository ahead of the record set.
Event feed
Each event carries the consequence Aims Dog proposes, not just the commit message.
| Date | Type | Reference | Commit | Message | Proposed consequence | |
|---|---|---|---|---|---|---|
| 2026-07-27 | pull-request | #412 | 77b0aa3 | Add second input modality: OCT volumes a.nowak | Outside the declared Controlled Evolution boundary. Requires a new authorisation and a new Basic UDI-DI. | |
| 2026-07-22 | push | main | 4de90c1 | Site-level threshold recalibration, northern cohort tim.verstraete | Performance changes. Freeze a new AI Model Version, open a change authorisation review, and assign a new UDI-DI. | |
| 2026-05-11 | tag | v4.2.1 | 1a77e2b | Fix DICOM loader crash on 12-bit input tim.verstraete | Defect correction. Evaluate as UDI-PI only. | Answered |
| 2026-01-26 | release | v4.2.0 | 9f13c7a | Retrain on DV-003, recalibrate operating point tim.verstraete | Freeze AI Model Version MV-002 and run the UDI change evaluation. | Answered |
Versions bound to code
A model version without a commit is a claim without evidence.
| Version | Frozen | Commit | Environment | Datasets | State |
|---|---|---|---|---|---|
| MV-001 1.0.0 | 2024-11-08 | e2740c8 | python 3.11, torch 2.3.1, cuda 12.1, container sha256:4f9a… | 2 | Approved |
| MV-002 2.1.0 | 2025-12-15 | 9f13c7a | python 3.11, torch 2.4.0, cuda 12.4, container sha256:aa10… | 2 | Deployed |
| MV-003 2.2.0-candidate | 2026-07-02 | Not recorded | Not recorded | 0 | Draft |
| MV-004 1.3.0 | 2025-01-22 | Not recorded | Not recorded | 0 | Deployed |