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510(k) Data Aggregation

    K Number
    K111776
    Device Name
    DELTAVIEW MODEL 2.1
    Manufacturer
    RIVERAIN MEDICAL GROUP,LLC
    Date Cleared
    2011-12-28

    (188 days)

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

    RIVERAIN MEDICAL GROUP,LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.
    Device Description
    DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.
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    K Number
    K092363
    Device Name
    SOFTVIEW, MODEL 2.01
    Manufacturer
    RIVERAIN MEDICAL GROUP
    Date Cleared
    2010-03-18

    (225 days)

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

    RIVERAIN MEDICAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SoftView is intended to generate an enhanced, secondary digital radiographic image of the chest. The enhanced AP or PA image of the chest provides improved visibility of the lung parenchyma through bone suppression and tissue equalization, and may facilitate discerning the presence or absence of nodules. The SoftView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians on patients with risk of having lung nodules and is not intended to be used on pediatric patients.
    Device Description
    SoftView is a dedicated post-processing application which suppresses bone structures from digital radiographic image of the chest.
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    K Number
    K071492
    Device Name
    FIRSTVIEW
    Manufacturer
    RIVERAIN MEDICAL GROUP,LLC
    Date Cleared
    2007-08-28

    (90 days)

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

    RIVERAIN MEDICAL GROUP,LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FirstView™ is intended to display and manipulate x-ray images. The FirstView™ is indicated for displaying and manipulating chest x-ray images. It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians.
    Device Description
    The FirstView™ consists of a dedicated server that has been programmed with a database and server software, as well as client software that is loaded onto an existing workstation. New images, which may be a chest x-ray or CAD result, are sent to the FirstView™ server from a Digital or from the PACS network, prompting FirstView to query the PACS for additional images related to that study. The FirstView™ server manages the images within its Riverain proprietary database.
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