CHISON Medical Technologies Co., Ltd.
WUXI Jiangsu, CN
CHISON Medical Technologies Co., Ltd. appears in FDA device records in WUXI Jiangsu, CN. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for CHISON Medical Technologies Co., Ltd. between 2018 and 2026. The busiest year on record is 2021, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 6 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | |
| K202457 | M1 Surgical Face Mask | FXX | Substantially Equivalent | |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004753388 | 3004753388 | CHISON Medical Technologies Co., Ltd. | No.3 Changjiang South Road, Xinwu District, WUXI Jiangsu 214028 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain