# 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

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: May 22, 2026 after 163 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 202 ancestors in all.
No later device cites it as a predicate yet.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233697: SonoMax Series Digital Color Doppler Ultrasound System, CHISON Medical Technologies Co., Ltd. (2024) Summary page 5.

## Indications for use
The Sonoport Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD) +D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K253949
Methodology: https://510kreport.com/methodology