# K101008: Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments (Siui
- Decided: Jun 8, 2010 after 57 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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/K101008
Methodology: https://510kreport.com/methodology