# K223570: SonoAir Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: Mar 31, 2023 after 122 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: 24 generations back to K935595 (1995). 200 ancestors in all.
No later device cites it as a predicate yet.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162172: EBit Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2016) Summary page 4.

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

Source page: https://510kreport.com/device/K223570
Methodology: https://510kreport.com/methodology