# K192791: Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 27, 2019 after 58 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.
1 later device descends 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)
- K171900: Acclarix AX4 Diagnostic Ultrasound System, Edan Instruments, Inc. (2017) Summary page 4.

## Most influential descendants
- 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 Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. General clinical applications include: Abdominal Gynecology Obstetric Cardiac Small parts Urology Musculoskeletal Peripheral vascular Adult Cephalic

Source page: https://510kreport.com/device/K192791
Methodology: https://510kreport.com/methodology