DeviceClearance

Product code SHP— Cardiovascular

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

Classification name
Cardiac Amyloidosis Machine Learning-Based Notification Software
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SHP under 21 CFR 870.2380, via openFDA

Market context for product code SHP

FDA has cleared 1 device under product code SHP, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHP

Recent clearances under product code SHP

Data sourced from openFDA. This site is unofficial and independent of the FDA.