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510(k) Data Aggregation

    K Number
    K052618
    Device Name
    IMAGECAST PACS
    Manufacturer
    Date Cleared
    2005-11-17

    (55 days)

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

    IDX SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Imagecast™ PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
    Device Description
    The Imagecast™ PACS is a modification of the iSite PACS that replaces the iSite worklist software with the Imagecast™ Worklist software. The Imagecast™ PACS is designed to optimize the clinician's workflow, and targets activities fundamental to their work: organizing, finding, reading, sharing and reporting. The Imagecast™ PACS trade name is also currently in use by IDX to resell the iSite PACS product.
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    K Number
    K954071
    Device Name
    IDXVIEW
    Manufacturer
    Date Cleared
    1996-02-27

    (181 days)

    Product Code
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDX SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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