1 device · 1 company · 2026
Product code SHP: Cardiac Amyloidosis Machine Learning-Based Notification Software
1 device under product code SHP, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Cardiac Amyloidosis Machine Learning-Based Notification Software. 21 CFR 870.2380, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ECG-AI Cardiac AmyloidosisK253801 · 510(k) | Anumana, Inc. | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.