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    K Number
    K062376
    Device Name
    DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
    Manufacturer
    RF SYSTEMS LAB.
    Date Cleared
    2006-10-27

    (73 days)

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

    RF SYSTEMS LAB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures. "The device must not be used for primary diagnosis in mammography."
    Device Description
    Direct Digital Radiography CCD Imaging Sensor NAOMI
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