# K103144: Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments (Siui
- Decided: Jan 12, 2011 after 79 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: 5 generations back to K935595 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092907: Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array Transducer, Phased Arr, Shantou Institute of Ultrasonic Instuments (2010) Summary page 2.

## Indications for use
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Source page: https://510kreport.com/device/K103144
Methodology: https://510kreport.com/methodology