5 devices · 1 company · 2023 to 2026
Anumana, Inc.: AI-enabled devices on FDA's list
5 devices from Anumana, Inc., 2023 to 2026, from 1 company across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Anumana, Inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| WatchMate SoftwareK260300 · 510(k) | Radiology | QIH | database entry | |
| ECG-AI Cardiac AmyloidosisK253801 · 510(k) | Cardiovascular | SHP | database entry | |
| ECG-AI Pulmonary HypertensionK252360 · 510(k) | Cardiovascular | SAT | database entry | |
| ECG-AI Low Ejection FractionK250652 · 510(k) | Cardiovascular | QYE | database entry | |
| Low Ejection Fraction AI-ECG AlgorithmK232699 · 510(k) | Cardiovascular | QYE | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.