Data / Medical devices / China / CHISON Medical Technologies Co., Ltd.
CHISON Medical Technologies Co., Ltd.: FDA-registered device maker in WUXI Jiangsu, China, 15 510(k) clearances
CHISON Medical Technologies Co., Ltd. is registered with the FDA (registration 3004753388) in WUXI Jiangsu, China. It lists 5 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004753388
- Address
- No.3 Changjiang South Road, Xinwu District No.9, Xinhuihuan Road, Xinwu District, WUXI Jiangsu, China, 214028
- Owner or operator
- CHISON Medical Technologies Co., Ltd. (9066279)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 5, 2013
- Registered through
- 2026
- Brand names listed
- 7L/3S/ 3C/ 6MC/ 6E, C3,L7SVA,P3, C3-A,MC3-A,,V6-A,L7M-A,L7S-A,R7-A,P3-A,MC6-A, C3-E,C3S-E,L7-E,L7W-E,L12-E,P2-E,P3-E,P6-E,V6-E,V7W-E,V7-E,L7R-E Diagnostic Ultrasound Transducer, C3-T,C3S-T,C3M-T,C3H-T,C3MS-T,C3T-T, L7-T,L7M-T,L12-T,L18-T,L7SVA-T,L8M-T,L8M5-T, L12M-T,L8M6-T ,L7R-T, L10i-T,E6-T,E7-T, C3-V,C3M-V, C3T-V,L7-V, L7SVA-V,L8Mb-V,L12b-V,L8M-V,L12-V, L12M-V, C3S-ES,P2-ES,V7-ES,7B8-E,T5-E,MT5-E,CW2-E,L18-E,i7L-E Diagnostic Ultrasound Transducer, CBit 1/2/3/4/5/6/7/8/9/10Digital Color Doppler Ultrasound System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | 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 | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| August 9, 2024 | K233697 | SonoMax Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| March 31, 2023 | K223570 | SonoAir Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| March 2, 2021 | 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 | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| February 25, 2021 | K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| February 25, 2021 | K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| August 5, 2020 | K200780 | XBit Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| August 17, 2018 | K180974 | CBit Series Digital Color Doppler Ultrasound System | IYN | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. | accessdata.fda.gov |
| July 6, 2017 | K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| June 6, 2017 | K170374 | SonoBook Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| September 14, 2016 | K162172 | EBit Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| July 28, 2015 | K150861 | QBit Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
| August 1, 2013 | K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | IYN | Substantially Equivalent | Chison Medical Imaging Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of System, Image Processing, Radiological
Updated May 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.