# K142982: OPUS 5100 Diagnostic Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chang Gung Medical Technology Co., Ltd.
- Decided: Sep 3, 2015 after 323 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: 2 generations back to K112602 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131088: Portable Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2013) Summary page 27.

## Indications for use
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular. The following transducers are intended for use with OPUS 5100 Diagnostic Doppler Ultrasound System.

Source page: https://510kreport.com/device/K142982
Methodology: https://510kreport.com/methodology