4 devices · 1 company · 2018 to 2024
EchoNous, Inc.: AI-enabled devices on FDA's list
4 devices from EchoNous, Inc., 2018 to 2024, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from EchoNous, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| KosmosK233826 · 510(k) | Radiology | IYN | database entry | |
| KosmosK212100 · 510(k) | Radiology | IYN | database entry | |
| KOSMOSK193518 · 510(k) | Radiology | IYN | database entry | |
| UscanK181574 · 510(k) | Radiology | IYO | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.