# K180862: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 24, 2018 after 52 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 220 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171824: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System, Edan Instruments, Inc. (2017) Summary page 32.

## Most influential descendants
- K192879: Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (2020), 1 descendant of its own
- K250214: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (2025), 0 descendants of its own
- K190186: Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System (2019), 0 descendants of its own

## Indications for use
The 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 Pediatric Neonatal (including abdominal and cephalic) Adult Cephalic

Source page: https://510kreport.com/device/K180862
Methodology: https://510kreport.com/methodology