# K171900: Acclarix AX4 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 18, 2017 after 53 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.
2 later devices descend from it; 1 cites it directly.
0 of 223 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). Cleared while this submission was under review Summary page 13.

## Most influential descendants
- K192791: Diagnostic Ultrasound System (2019), 1 descendant of its own
- K202856: Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 (2021), 0 descendants of its own

## Indications for use
The Edan AX4 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/K171900
Methodology: https://510kreport.com/methodology