# K190186: Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 28, 2019 after 55 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: 26 generations back to K935595 (1995). 221 ancestors in all.
No later device cites it as a predicate yet.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180862: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System, Edan Instruments, Inc. (2018) Summary page 22.

## 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/K190186
Methodology: https://510kreport.com/methodology