# K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems

- Pathway: 510(k) (Traditional)
- Applicant: Supersonic Imagine
- Decided: Jan 9, 2018 after 103 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: 22 generations back to K935595 (1995). 331 ancestors in all.
18 later devices descend from it; 2 cite it directly.
7 of 350 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171105: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems, Supersonic Imagine (2017) Summary page 4.
- K170445: Logiq S8, GE Healthcare (2017) Summary page 17.
- K160524: FibroScan 530 Compact, Echosens (2016) Summary page 17.

## Most influential descendants
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (2020), 7 descendants of its own
- K212333: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (2022), 6 descendants of its own
- K223017: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (2023), 5 descendants of its own

## Indications for use
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for:- Measurements of abdominal anatomical structures,- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,- Measurements of brightness ratio between liver and kidney,- Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion. The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.

Source page: https://510kreport.com/device/K173021
Methodology: https://510kreport.com/methodology