| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | 4 | 2023-03-02 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-03-02 | K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | IYO | Class II | Radiology |
| 2021-07-30 | K212035 | FibroScan 230 | IYO | Class II | Radiology |
| 2021-03-25 | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | IYO | Class II | Radiology |
| 2020-07-16 | K200655 | FibroScan® 630 | IYO | Class II | Radiology |