# K102989: Opus Diagnostic Ultrasound System & Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Chang Gung Medical Technology Co., Ltd. Linkou Fac
- Decided: Dec 9, 2010 after 64 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.
4 later devices descend from it; 1 cites it directly.
0 of 10 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 2.

## Most influential descendants
- K132690: UP600 Diagnostic Doppler Ultrasound System (2014), 3 descendants of its own
- K172056: InnoSight Diagnostic Ultrasound System (2017), 2 descendants of its own
- K181313: BenQ Diagnostic Ultrasound System (2018), 1 descendant of its own
- K192254: InnoSight Diagnostic Ultrasound System (2019), 0 descendants of its own

## 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, tests, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (conventional), Ob/Gyn and Urology.

Source page: https://510kreport.com/device/K102989
Methodology: https://510kreport.com/methodology