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510(k) Data Aggregation

    K Number
    K062059
    Device Name
    AIE REGION OF INTEREST IMAGE ENHANCEMENT
    Manufacturer
    ADVANCED IMAGE ENHANCEMENT
    Date Cleared
    2006-09-06

    (48 days)

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

    ADVANCED IMAGE ENHANCEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician or healthcare professional for display. manipulation and interpretation of lossless compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The AIE software is intended as an added tool residing on any DICOM image workstation for improving the radiologist's perception of image features on any lossless compressed or noncompressed multi-modality DICOM "for-presentation" image. This software would be used while the radiologist is reviewing magnification window image segments on FDA cleared monitors and is intended to complement existing DICOM image workstation functionality. Warning: 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 FDA.
    Device Description
    The Region of Interest Image Enhancement for Digital Mammography (ROILE-DM) software created by Advanced Image Enhancement, Inc. is intended to improve the overall ability of an image reader to resolve abnormalities with greater confidence in their findings. The AIE software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or noncompressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The intended operational environment is the radiology reading room or any other FDA approved environment.
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