# K150002: iNSIGHT Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Saset (Chengdu), Inc.
- Decided: Jun 23, 2015 after 172 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: 15 generations back to K935595 (1995). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090059: Imago C21 Diagnostic Ultrasound System, Saset (Chengdu), Inc. (2009) Summary page 11.
- K130881: Acuson S2000 and S3000, Siemens Medical Solutions USA, Inc. (2013) Summary page 11.

## Indications for use
The iNSIGHT Color Doppler Ultrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

Source page: https://510kreport.com/device/K150002
Methodology: https://510kreport.com/methodology