2 devices · 1 company · 2023
BK Medical Aps: AI-enabled devices on FDA's list
2 devices from BK Medical Aps, 2023, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Ultrasound System 1300K231764 · 510(k) | Radiology | IYN | database entry | |
| Ultrasound System 2300K223830 · 510(k) | Radiology | IYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.