510(k) K253949 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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, SonoPo
| Applicant | CHISON Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Dec 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253949
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.