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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
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-DIUDI-PICarrierRegistrationRegisteredChange
(01)054123450000344.2.0Plain text on screenRegistered2026-02-04Retrained on an extended dataset version. Sensitivity and specificity both changed, so a new UDI-DI was assigned.
(01)054123450000274.0.0Plain text on screenSuperseded2025-02-20First market release of the screening classifier.
(01)054123450000414.3.0Plain text on screenNot registeredNot recordedThreshold 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.

DateChangeOutcomeDecided byReasoning
2026-05-12Release 4.2.1, image loader defectNew UDI-PI onlyBron HelstromA defect correction with no effect on safety, performance or the interpretation of data. Only the version number moves.
2026-01-28Release 4.2.0, retraining on DV-003New UDI-DIBron HelstromThe change affects performance, so a new UDI-DI is assigned and registered; the previous one is superseded.