# K161300: Acclarix AX8 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: May 31, 2016 after 22 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: 22 generations back to K935595 (1995). 189 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150999: Acclarix Diagnostic Ultrasound System, Edan Instruments, Inc. (2015) Summary page 15.
- K142511: U50 Diagnostic Ultrasound System, Edan Instruments, Inc. (2015) Summary page 15.

## Most influential descendants
- 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
- K171900: Acclarix AX4 Diagnostic Ultrasound System (2017), 2 descendants of its own
- K192879: Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (2020), 1 descendant 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/K161300
Methodology: https://510kreport.com/methodology