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510(k) Data Aggregation

    K Number
    K063539
    Device Name
    NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
    Manufacturer
    NORDICICEMEDICAL AS
    Date Cleared
    2007-01-17

    (54 days)

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

    NORDICICEMEDICAL AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nordic Image Control and Evaluation (nICE) Software 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.
    Device Description
    Nordic Image Control and Evaluation (nICE) Software is a medical imaging manipulation tool, designed to provide a way to optimize the clinician's workflow. It targets activities fundamental to their work: reading, defining, sharing and reporting medical radiographic images. It is designed to work within a Windows™ operating system, and provides the user with the ability to view a wide range of image types.
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