Triage or detection: what your imaging AI is actually cleared to say

A hospital buys two AI products. Both report intracranial haemorrhage. One is cleared for triage and notification, the other for detection. In the vendor demo they look identical. In regulatory terms they are different devices making different claims, and presenting them the same way quietly upgrades one of them on the vendor behalf.

Triage and notification says look sooner

A CADt device prioritises and notifies. It says this study should be read before the others in the queue. It does not assert that a finding is present, it is not for primary diagnosis, and the radiologist reads the study exactly as they would have anyway.

That narrower claim is why triage devices are a lighter regulatory object and why most of the emergency imaging AI on the market is cleared this way.

Detection says there is something here

A CADe device marks the location of a suspected finding. That is a broader claim and it changes what the radiologist is looking at while they read, which is why it carries a heavier evidentiary burden.

Characterisation goes further again. A CADx device says something about the nature of a finding, benign or malignant, and sits higher still.

The reported finding list is usually wider than the cleared finding list, and the cleared list differs by market. Both facts get lost in a product brochure.

Why this constrains the software showing you the result

If a device is cleared for triage and notification, a worklist that renders its output as a stated finding next to the patient name has made a diagnostic claim the manufacturer never made and cannot support. The hospital, not the vendor, is now the one asserting it.

The practical answer is to track the claim type per device and let it drive presentation. A triage result reorders the queue and says why. A detection result may mark a location. Neither borrows the other privileges.

Questions worth asking before a device reaches a radiologist

• What claim type is this cleared for in this country: triage, detection, or characterisation?
• Which specific findings are inside the clearance, as opposed to reported by the product?
• What does the intended use statement say, verbatim?
• Does our viewer present it in a way consistent with that statement?