# K202455: Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

- Pathway: 510(k) (Special)
- Applicant: Supersonic Imagine
- Decided: Dec 29, 2020 after 124 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). 435 ancestors in all.
No later device cites it as a predicate yet.
7 of 436 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191007: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems, Supersonic Imagine (2019) Summary page 4.

## Indications for use
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH 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® MACH 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 shearwave speed, beam attenuation, viscosity 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 and pediatric patients with liver disease. The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.

Source page: https://510kreport.com/device/K202455
Methodology: https://510kreport.com/methodology