# K150999: Acclarix Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 6, 2015 after 21 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: 21 generations back to K935595 (1995). 187 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123249: Diagnostic Ultrasound System, Edan Instruments, Inc. (2013) Summary page 12.
- K131690: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 12.

## Most influential descendants
- K161300: Acclarix AX8 Diagnostic Ultrasound System (2016), 9 descendants of its own
- K160790: Acclarix LX8 Diagnostic Ultrasound System (2016), 9 descendants of its own
- K162055: Acclarix LX8 Diagnostic Ultrasound System (2017), 8 descendants of its own
- K171824: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (2017), 7 descendants of its own
- K180862: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (2018), 3 descendants of its own

## Indications for use
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative

Source page: https://510kreport.com/device/K150999
Methodology: https://510kreport.com/methodology