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510(k) Data Aggregation

    K Number
    K030635
    Device Name
    THE OBSIDIAN PACS SYSTEM
    Date Cleared
    2003-03-28

    (28 days)

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

    OBSIDIAN MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses. The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.
    Device Description
    The Obsidian PACS System is comprised of components that connect to an analog or digital medical imaging device (ultrasound, CT, MRI, digitizer), transmit image or patient data, and store image or patient data. The transmission of data can occur internally or externally using a local area network or Internet connection.
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