SHP

Cardiac Amyloidosis Machine Learning-Based Notification Software

Product code

SHP

Device name

Cardiac Amyloidosis Machine Learning-Based Notification Software

Device class

Class 2

21 CFR

21 CFR 870.2380

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-04-07.

1 summaries are archived here for direct download.