# K081110: Siui CTS-900 Digital Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Shantou Institute of Ultrasonic Instuments
- Decided: May 16, 2008 after 28 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000030 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061083: CTS-7700, Shantou Institute of Ultrasonic Instuments (2006) Summary page 1.
- K070982: CTS-7700 Digital Ultrasound Imaging System, Shantou Institute of Ultrasonic Instuments (2007) Summary page 1.

## Indications for use
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.

Source page: https://510kreport.com/device/K081110
Methodology: https://510kreport.com/methodology