# K110999: Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Apr 26, 2011 after 15 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: 13 generations back to K935595 (1995). 91 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091680: Digital Ultrasonic Diagnostic Imaging System, Edan Instruments, Inc. (2009) Summary page 1.
- K081320: DC-3, DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K160790: Acclarix LX8 Diagnostic Ultrasound System (2016), 9 descendants of its own

## Indications for use
The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The 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/K110999
Methodology: https://510kreport.com/methodology