(53 days)
The SuperSonic Imagine® SuperSonic® Hepa Vi™ 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 ID : 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); Shear Wave Elastography (SWE); Shear Wave dispersion Viscosity (Vi PLUS); Combination Modes [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/ SWE); (B/M-mode/Color flow)].
In addition, the SuperSonic® HepaVu™ 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, 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 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.
1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.
The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic hepatology purpose ultrasound imaging studies.
The system contains a scan converter and can be coupled to a variety of linear and curved trransducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.
The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
The principle software change with respect to the MACH software version is related to the following feature:
- -Backscattering coefficient (BSc): The backscattering coefficient characterizes the ability of a tissue to reflect incoming ultrasound wave back to the direction from which they came. Local measurement of the backscattering is expressed in db/cm.str over a range of values (from -38 db/cm.str to -24 db/cm.str).
Bsc PLUS mode is available for all Abdominal presets on C6-1X and C9-2X transducers.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the SuperSonic® HepaVu™ ultrasound diagnostic system, outlining its indications for use, technological characteristics compared to a predicate device, and non-clinical testing for substantial equivalence. It explicitly states that "No clinical tests have been performed on SuperSonic® HepaVu™ System." Therefore, the requested information cannot be extracted from this document.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.