# K091877: Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Sep 2, 2009 after 71 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
Longest line of descent: 5 generations back to K933202 (1994). 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)
- K052042: Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers, Sonoscape Company Limited (2005) Summary page 1.

## Indications for use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); Heart Soft Tissue; Peripheral Vascular; Musculo-skeletal (conventional) and Urology.

Source page: https://510kreport.com/device/K091877
Methodology: https://510kreport.com/methodology