# K172931: DUS-6000 Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Dec 1, 2017 after 67 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131830: Digital Ultrasonic Diagnostic Imaging System, Edan Instruments, Inc. (2013) Summary page 15.

## Indications for use
The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac applications by or on the order of a physician or similarly qualified health care professional.

Source page: https://510kreport.com/device/K172931
Methodology: https://510kreport.com/methodology