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510(k) Data Aggregation

    K Number
    K242223
    Device Name
    SuperSonic HepaVu
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2024-09-20

    (53 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K222191
    Device Name
    Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
    Manufacturer
    SuperSonic Imagine
    Date Cleared
    2022-10-28

    (98 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SuperSonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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 diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], 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); Shear Wave 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); (B/Strain Elastography/SWE)]. In addition, the Hologic SuperSonic 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 visualization of vascularization, microvascularization and perfusion 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 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.
    Device Description
    The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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 PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
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    K Number
    K203645
    Device Name
    Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
    Manufacturer
    SuperSonic Imagine
    Date Cleared
    2021-06-29

    (197 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SuperSonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. Furthermore, the SuperSonic Imagine AIXPLORER® MACH / 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.
    Device Description
    The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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 submodes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging-also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.
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    K Number
    K202455
    Device Name
    Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2020-12-29

    (124 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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 Musculosketal, 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 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.
    Device Description
    The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart-based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear and phased array transducers 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), Mmode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.
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    K Number
    K191007
    Device Name
    Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2019-10-25

    (192 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperSonic Imagine AIXPLORER® 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 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, Intraoperative, OB-CYN, Pelvic, Pediatric, Urology, Transrectal, 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 visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
    Device Description
    The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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-Color Flow Imaging, CPI-Color Power Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaye™ elastography and Strain Elastography.
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    K Number
    K180572
    Device Name
    AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2018-05-29

    (85 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperSonic Imagine AIXPLORER® MACH 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® 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, Transrectal, 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 shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
    Device Description
    The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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 PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
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    K Number
    K173021
    Device Name
    Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2018-01-09

    (103 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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, 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 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 of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.
    Device Description
    The SuperSonic Inagine AIXPLORER® & AIXPLORER® Utimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in 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 CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
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    K Number
    K171105
    Device Name
    AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
    Manufacturer
    Supersonic Imagine
    Date Cleared
    2017-07-11

    (89 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Supersonic Imagine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pediatric, Urology, Trans-rectal, Transvaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
    Device Description
    The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate are a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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, and Angio PL.U.S), Pulsed Wave Doppler, 3D imaging and for ShearWave™ elastography.
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    K Number
    K161999
    Device Name
    Aixplorer
    Manufacturer
    SUPERSONIC IMAGINE
    Date Cleared
    2016-11-16

    (119 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPERSONIC IMAGINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
    Device Description
    The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, 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 function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.
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    K Number
    K142100
    Device Name
    AIXPLORER
    Manufacturer
    SUPERSONIC IMAGINE
    Date Cleared
    2014-11-20

    (111 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPERSONIC IMAGINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications: Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Neonatal/ Adult Cephalic, Fetal/Obstetrics).
    Device Description
    The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
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