SII

Aortic Stenosis Machine Learning-Based Notification Software

Product code: SII
Device name: Aortic Stenosis Machine Learning-Based Notification Software
Device class: Class 2
21 CFR: 21 CFR 870.2380
Medical specialty: Cardiovascular
Marketing pathway: 510(K)

FDA classification definition

Aortic Stenosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of aortic stenosis for further referral or diagnostic follow-up.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SII

Classification and pathway per current FDA publications. Data from openFDA (CC0).