# K012772: CTS-485 Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instuments
- Decided: Oct 1, 2001 after 45 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: 1 generation back to K000030 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000030: Sonoace 600 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- K061083: CTS-7700 (2006), 1 descendant of its own
- K081110: Siui CTS-900 Digital Ultrasound Imaging System (2008), 0 descendants of its own
- K061488: CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System (2006), 0 descendants of its own

## Indications for use
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.

Source page: https://510kreport.com/device/K012772
Methodology: https://510kreport.com/methodology