Aortic Stenosis Machine Learning-Based Notification Software

FDA product code SII · Class II (moderate risk) · 21 CFR 870.2380 · Cardiovascular

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.

0510(k) clearances
0PMA approvals
0recalls