Company ยท FR
Sonio
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|
| Jun 4, 2026 | K261519 | Sonio Suspect Sonio, FR | POK |
| Mar 16, 2026 | K252433 | Sonio Detect (v3) Sonio, FR | IYN |
| Feb 21, 2025 | K243614 | Sonio Suspect Sonio, FR | POK |
| Apr 26, 2024 | K240406 | Sonio Detect Sonio, FR | IYN |
| Jul 25, 2023 | K230365 | Sonio Detect Sonio, FR | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|
| No recalls in this window. |