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510(k) Data Aggregation

    K Number
    K033912
    Device Name
    CRADLE PACS
    Manufacturer
    CRADLE TECHNOLOGY CORP.
    Date Cleared
    2004-05-11

    (146 days)

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

    CRADLE TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CRADLE HIPAX PACS device is intended for the manipulation, . management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
    Device Description
    CRADLE HIPAX PACS consists of databank mainframe, file storage backup system, medical tomography interlink, job query, image diagnose and archive, and medical information integral linking modules and subsystems.
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