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510(k) Data Aggregation

    K Number
    K243862
    Device Name
    LVivo Software Application
    Manufacturer
    DiA Imaging Analysis Ltd.
    Date Cleared
    2025-03-17

    (91 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiA Imaging Analysis Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age >18. In addition, it has the ability to provide Quality Score feedback.
    Device Description
    The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart utilizing the apical views. Global LV function evaluation by ejection fraction (EF) is done based on two of the apical views: four-chamber (4CH) and two-chamber (2CH). Segmental LV function evaluation is done from three apical views 4CH, 2CH and three chamber (3CH) and supports segmental wall motion evaluation and strain. The LVivo platform supports also LV function evaluation from the parasternal views including global and segmental LV function analysis from the Short Axis (SAX) view and the global LV function analysis form the Parasternal Long Axis (PLAX) views. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume. The LVivo Platform includes also two additional configurations: LVivo Seamless for offline analysis based on automatically selected views and LVivo IQS for real-time quality feedback during image acquisition
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    K Number
    K243331
    Device Name
    LVivo Seamless
    Manufacturer
    DiA Imaging Analysis Ltd.
    Date Cleared
    2025-03-06

    (133 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiA Imaging Analysis Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease of patients and Age >18.
    Device Description
    The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 30d party software. The results are sent to the PACS and are evaluated by a healthcare professional.
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    K Number
    K243235
    Device Name
    LVivo Software Application
    Manufacturer
    DiA Imaging Analysis Ltd.
    Date Cleared
    2025-03-03

    (144 days)

    Product Code
    QIH, OIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiA Imaging Analysis Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
    Device Description
    The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. LVivo CE-EF (Contrast EF) extends the current toolbox of the LVivo platform by providing the ability to process Ultrasonic DICOM images which acquire by Ultrasound Equipment in which the patient was prescribed a contrast agent. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
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    K Number
    K240553
    Device Name
    LVivo Software Application
    Manufacturer
    DiA Imaging Analysis Ltd.
    Date Cleared
    2024-10-04

    (219 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiA Imaging Analysis Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
    Device Description
    The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal Short Axis (SAX) view and the Parasternal Long Axis view (PLAX). LVivo PLAX extends the current toolbox of the LVivo platform, providing automated calculation of LV size and function parameters from the PLAX view, for cardiac function evaluation as part of the standard echocardiographic assessment in Echo environment and point-of-care. The measurements from the PLAX view add information about the contraction of the LV, its size and wall thickness and can be used for rapid evaluation of the patient's condition in the point-of-care. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function and the LVivo Seamless. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
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    K Number
    K240769
    Device Name
    LVivo IQS
    Manufacturer
    DiA Imaging Analysis Ltd.
    Date Cleared
    2024-05-24

    (64 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiA Imaging Analysis Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
    Device Description
    The LVivio IQS is an extension to the LVivio IQS (K222970), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, is a medical device accessory.
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