5 devices · 1 company · 2023 to 2026
Sonio: AI-enabled devices on FDA's list
5 devices from Sonio, 2023 to 2026, 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 (5 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Sonio
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Sonio SuspectK261519 · 510(k) | Radiology | POK | database entry | |
| Sonio DetectK252433 · 510(k) | Radiology | IYN | database entry | |
| Sonio SuspectK243614 · 510(k) | Radiology | POK | database entry | |
| Sonio DetectK240406 · 510(k) | Radiology | IYN | database entry | |
| Sonio DetectK230365 · 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.