# 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

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 25, 2021 after 119 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: 27 generations back to K935595 (1995). 222 ancestors in all.
No later device cites it as a predicate yet.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192791: Diagnostic Ultrasound System, Edan Instruments, Inc. (2019) Summary page 20.

## Indications for use
The Acclarix AX3 series/Acclarix LX3 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, Intra-operative, Pediatric, Neonatal , Adult Cephalic. The modes of operation for Acclarix AX3 series/Acclarix LX3 series include B mode, M mode, Doppler mode, Harmonic Imaging, and their combination modes.

Source page: https://510kreport.com/device/K202856
Methodology: https://510kreport.com/methodology