# K061488: CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System

- Pathway: 510(k) (Special)
- Applicant: Shantou Institute of Ultrasonic Instruments (Siui
- Decided: Jun 30, 2006 after 30 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: 2 generations back to K000030 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012772: CTS-485 Ultrasound Imaging System, Shantou Institute of Ultrasonic Instuments (2001) Summary page 1.

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

Source page: https://510kreport.com/device/K061488
Methodology: https://510kreport.com/methodology