# K132690: UP600 Diagnostic Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Qisda Corporation
- Decided: Feb 25, 2014 after 181 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: 5 generations back to K933202 (1994). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102989: Opus Diagnostic Ultrasound System & Transducers, Chang Gung Medical Technology Co., Ltd. Linkou Fac (2010) Summary page 1.
- K053435: GE Voluson I, General Electric Co. (2005) Summary page 1.

## Most influential descendants
- 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, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric. Fetal. Cephalic, ObfGyn, Trans-rectal, Trans-vaginal, Urology.

Source page: https://510kreport.com/device/K132690
Methodology: https://510kreport.com/methodology