# K172055: DUS-7000 Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Aug 31, 2017 after 56 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: 20 generations back to K935595 (1995). 197 ancestors in all.
No later device cites it as a predicate yet.
6 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142815: S22 Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2015) Summary page 26.

## Indications for use
The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K172055
Methodology: https://510kreport.com/methodology