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510(k) Data Aggregation

    K Number
    K073670
    Device Name
    KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
    Manufacturer
    OREX COMPUTED RADIOGRAPHY LTD
    Date Cleared
    2008-01-25

    (29 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    OREX COMPUTED RADIOGRAPHY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
    Device Description
    Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
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    K Number
    K032654
    Device Name
    PORT CASSETTE
    Manufacturer
    OREX COMPUTED RADIOGRAPHY LTD
    Date Cleared
    2003-10-09

    (42 days)

    Product Code
    IXK
    Regulation Number
    892.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    OREX COMPUTED RADIOGRAPHY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).
    Device Description
    The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.
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    K Number
    K003256
    Device Name
    PCCR DIGITAL IMAGING DEVICE
    Manufacturer
    OREX COMPUTED RADIOGRAPHY LTD
    Date Cleared
    2000-11-08

    (22 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    OREX COMPUTED RADIOGRAPHY LTD

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