# K242223: SuperSonic HepaVu

- Pathway: 510(k) (Special)
- Applicant: Supersonic Imagine
- Decided: Sep 20, 2024 after 53 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: 29 generations back to K935595 (1995). 437 ancestors in all.
No later device cites it as a predicate yet.
7 of 438 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222191: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40, Supersonic Imagine (2022) Summary page 6.

## Indications for use
The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound diagnostic system 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® SuperSonic® HepaVu™ ultrasound system is indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric. Modes of operation include: B-mode [2D ; Panoramic Imaging; Spatial Compounding], M-mode, Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); ShearWave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow)]. In addition, the SuperSonic Imagine® SuperSonic® HepaVu™ range 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, ultrasound attenuation coefficient, backscattering coefficient, 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. This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician’s office This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

Source page: https://510kreport.com/device/K242223
Methodology: https://510kreport.com/methodology