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510(k) Data Aggregation

    K Number
    K023467
    Device Name
    HCP DICOM NET
    Date Cleared
    2003-01-07

    (83 days)

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

    SOFTLINK INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HCP DICOM Net® is a software device intended to acquire and store medical images studies from catheterization laboratories, Echo cardiograms, CT & MRI and other such modalities. In addition, HCP DICOM Net® provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CD's/DVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net® also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.
    Device Description
    HCP DICOM Net® is a computerized system that acquires images which are captured by cardiac catherterization laboratories and other modalities like Echocardiograms. MRI & CT. These images are acquired through a video source or a DICOM3 interface of the modality. These images are then stored in DICOM3 format on Hard Disk Drives, Magnetic Tape. CD-R or DVD. If images are acquired through a video source, in a non-DICOM3 format then these images are converted into a DICOM3 format before they are stored. After storage these images are retrieved and displayed on workstations for convenient review and analysis. Analysis of images is provided via approved industry standard third party software. These workstations are also capable of reading DICOM3 images from CD and DVD media and uploading them to the image store for retrieval, viewing and analysis at a later time.
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