# K141720: iuStar300 Medical Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: United Imaging Systems (Beijing) Co., Ltd.
- Decided: Jul 23, 2015 after 393 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: 18 generations back to K935595 (1995). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061946: Acuson X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 11.
- K110510: S20 Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2011) Summary page 11.

## Indications for use
The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial 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/K141720
Methodology: https://510kreport.com/methodology