| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 3 | 2026-03-16 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Class II | Radiology | 2 | 2026-06-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-04 | K261519 | Sonio Suspect | POK | Class II | Radiology |
| 2026-03-16 | K252433 | Sonio Detect (v3) | IYN | Class II | Radiology |
| 2025-02-21 | K243614 | Sonio Suspect | POK | Class II | Radiology |
| 2024-04-26 | K240406 | Sonio Detect | IYN | Class II | Radiology |
| 2023-07-25 | K230365 | Sonio Detect | IYN | Class II | Radiology |