Valvular Regurgitation Machine Learning-Based Notification Software

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

Valvular regurgitation machine learning-based notification software employs machine learning techniques to suggest the likelihood of valvular regurgitation for further referral or diagnostic follow-up.

0510(k) clearances
0PMA approvals
0recalls