# K222191: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

- Pathway: 510(k) (Traditional)
- Applicant: Supersonic Imagine
- Decided: Oct 28, 2022 after 98 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: 28 generations back to K935595 (1995). 436 ancestors in all.
1 later device descends from it; 1 cites it directly.
7 of 438 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203645: Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40, Supersonic Imagine (2021) Summary page 5.

## Most influential descendants
- K242223: SuperSonic HepaVu (2024), 0 descendants of its own

## Indications for use
The Hologic SuperSonic Imagine 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 Hologic SuperSonic SUPERSONIC MACH range 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. Modes of operation include: B-mode [20D; 3D ; Panoramic Imaging; Spatial Compounding 1, M-mode, Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S) ], Strain Elastography, 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'CW); (B.M-mode/Color flow); (B/Strain Elastography/SWE)). In addition, the Hologic SuperSonic Imagine SUPERSONIC MACH 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 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. Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for: - Measurements of breast anatomical structures - Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast - Visualization of breast structures and micro-vascularization - Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping. The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound. 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/K222191
Methodology: https://510kreport.com/methodology