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510(k) Data Aggregation

    K Number
    K990248
    Device Name
    DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
    Manufacturer
    DICOMIT IMAGING SYSTEMS CORP.
    Date Cleared
    1999-04-16

    (80 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DICOMIT IMAGING SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation. The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
    Device Description
    The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
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