61 of 64 answered. 9 to confirm.

Step 2 of 7

Products

Product name · required

AI Triage Platform

From the IFU draft

Is it a medical device? · required

Yes No Not sure

From the IFU draft, section 1

Device classification · required

UKCA class I

Two sources disagreeThe IFU says class I. Your pitch deck says class IIa.Run a classification assessment

Does it use AI or machine learning? · required

Yes No

From qyro.co

UDI issued

Yes No

Answered by Zak, 9 Oct