# K171824: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jul 18, 2017 after 29 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: 24 generations back to K935595 (1995). 219 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K162055: Acclarix LX8 Diagnostic Ultrasound System, Edan Instruments, Inc. (2017) Summary page 26.

## Most influential descendants
- 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
- K250214: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (2025), 0 descendants of its own

## Indications for use
The Acclarix AX8 Diagnostic Ultrasound system/Acclarix LX8 Diagnostic 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/K171824
Methodology: https://510kreport.com/methodology