Wuxi, CN · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 9 | 2026-05-22 |
| FXX | — | — | — | 1 | 2021-04-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-22 | K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | IYN | Class II | Radiology |
| 2024-08-09 | K233697 | SonoMax Series Digital Color Doppler Ultrasound System | IYN | Class II | Radiology |
| 2023-03-31 | K223570 | SonoAir Series Digital Color Doppler Ultrasound System | IYN | Class II | Radiology |
| 2021-04-29 | K202457 | M1 Surgical Face Mask | FXX | — | — |
| 2021-03-02 | K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | IYN | Class II | Radiology |
| 2021-02-26 | K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | IYN | Class II | Radiology |
| 2021-02-26 | K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | IYN | Class II | Radiology |
| 2021-02-25 | K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | IYN | Class II | Radiology |
| 2021-02-25 | K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | IYN | Class II | Radiology |
| 2020-08-05 | K200780 | XBit Series Digital Color Doppler Ultrasound System | IYN | Class II | Radiology |