# K090229: Diagnostic Doppler Ultrasound System 2-5MHZ Curved Linear Array, 5-10MHZ Linear Array, 2-4MHZ Phase Array, 4-8MHZ Transv

- Pathway: 510(k) (Traditional)
- Applicant: Chang Gung Medical Supplies & Equipment Corp.
- Decided: Mar 13, 2009 after 42 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: 4 generations back to K933202 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042369: Sonoscape Ultrasound System Ssi-1000/Ssi-5000, Sonoscape Company Limited (2004) Summary page 1.

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Cardiac, Small Organ (breast, testes, thyroid); heart soft tissue; Peripheral Vascular; Musculo-skeletal (conventional); OB/Gyn and Urology.

Source page: https://510kreport.com/device/K090229
Methodology: https://510kreport.com/methodology