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
How the identifiers work
The Basic UDI-DI is the access key to the device in the technical documentation and in EUDAMED, and never appears on a trade item. The UDI-DI identifies a specific version and is the thing that is registered. For software the UDI-PI is the version number; it is never registered on its own, and it is what a reporter quotes in a vigilance case.
Basic UDI-DI
Assigned once per device. It moves only when the device becomes a different device.
Code
5412345000010ZK
Issuing entity
GS1
Risk class
Class IIa (MDR)
Assigned on
2024-06-03
Intended purpose
Detection of referable diabetic retinopathy in colour fundus images, for prioritisation of specialist review.
Essential characteristics
Convolutional image classifier operating on a pair of 45-degree colour fundus images. Advisory output. No therapeutic actuation.
Notified body
NB 0344 / CE 812-MDR-24
UDI-DI and UDI-PI
One UDI-DI per released version. The UDI-PI is the version number and carries no registration of its own.
| UDI-DI | UDI-PI | Carrier | Registration | Registered | Change | |
|---|---|---|---|---|---|---|
| (01)05412345000027 | 4.0.0 | Plain text on screen | Superseded | 2025-02-20 | First market release of the screening classifier. | |
| (01)05412345000034 | 4.2.0 | Plain text on screen | Registered | 2026-02-04 | Retrained on an extended dataset version. Sensitivity and specificity both changed, so a new UDI-DI was assigned. | |
| (01)05412345000041 | 4.3.0 | Plain text on screen | Not registered | Not recorded | Threshold recalibration for the northern sites. Performance changes, so registration is required before release. |
Evaluate a change
State what the change affects. The answer decides which identifier moves.
Change
Outcome
No UDI change
No effect is declared, so no identifier moves. Declare the effects to evaluate.
No identifier moves. The change is recorded in the audit trail only.
Recorded evaluations
Every change evaluation is kept.
| Date | Change | Outcome | Decided by | Reasoning |
|---|---|---|---|---|
| 2026-01-28 | Release 4.2.0, retraining on DV-003 | New UDI-DI | Bron Helstrom | The change affects performance, so a new UDI-DI is assigned and registered; the previous one is superseded. |
| 2026-05-12 | Release 4.2.1, image loader defect | New UDI-PI only | Bron Helstrom | A defect correction with no effect on safety, performance or the interpretation of data. Only the version number moves. |