# K091680: Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 19, 2009 after 9 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K934139 (1995). 17 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052113: DP-6600 Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2005) Summary page 1.
- K060949: DP-6600 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K110999: Digital Ultrasonic Diagnostic Imaging System (2011), 22 descendants of its own
- K123249: Diagnostic Ultrasound System (2013), 21 descendants of its own
- K142511: U50 Diagnostic Ultrasound System (2015), 13 descendants of its own
- K150999: Acclarix Diagnostic Ultrasound System (2015), 12 descendants of its own
- K161300: Acclarix AX8 Diagnostic Ultrasound System (2016), 9 descendants of its own

## Indications for use
The DUS 3 & DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 3/ DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Source page: https://510kreport.com/device/K091680
Methodology: https://510kreport.com/methodology