# K162055: Acclarix LX8 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 31, 2017 after 190 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: 23 generations back to K935595 (1995). 218 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160790: Acclarix LX8 Diagnostic Ultrasound System, Edan Instruments, Inc. (2016) Summary page 15.
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 15.
- K161300: Acclarix AX8 Diagnostic Ultrasound System, Edan Instruments, Inc. (2016) Summary page 15.

## Most influential descendants
- 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
- K192791: Diagnostic Ultrasound System (2019), 1 descendant of its own

## Indications for use
The Edan Acclarix LX8 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)

Source page: https://510kreport.com/device/K162055
Methodology: https://510kreport.com/methodology