SIK

Cardiac Hypertrophy Machine Learning-Based Notification Software

Product code

SIK

Device name

Cardiac Hypertrophy 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

Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy for further referral or diagnostic follow-up.

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