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510(k) Data Aggregation

    K Number
    K201411
    Device Name
    Visage Breast Density
    Date Cleared
    2021-01-29

    (246 days)

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

    Visage Imaging GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid.
    Device Description
    Visage Breast Density is a software application that assesses breast density from a mammography study and provides a density category A, B, C, or D according to the ACR BI-RADS Atlas 5th Edition to aid radiologists in the assessment of breast tissue composition. Visage Breast Density employs a convolutional network (CNN) for the automatic classification of breast density. The CNN has been trained on a large database of mammography exams. When applied to a mammography image, the CNN computes four likelihoods corresponding to the four breast density categories. The classifications of the individual images are merged into a general classification of the mammography study. Visage Breast Density is designed as an add-on module to the Visage 7 product for distributing, viewing, processing, and archiving medical images. The assessment of breast density is performed from mammography studies stored on the Visage 7 server. The resulting breast density classification is displayed by the Visage 7 client on a computer monitor and stored in the database on the Visage 7 server.
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    K Number
    K142196
    Device Name
    Visage Ease Pro
    Date Cleared
    2015-04-28

    (260 days)

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

    VISAGE IMAGING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: Xray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments. Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic decision resides with the doctors and/or the medical staff in their respective area of responsibility. Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complicable diagnostic requirements and the state-of-the-art. Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.
    Device Description
    Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments. Visage Ease Pro has a graphical user interface which is optimized for mobile devices with a touch screen. The app allows searching for studies and viewing images and reports. The user may zoom and pan images, adjust the window level, browse through a stack of images or play a cine animation. Patient and image information is displayed as viewer text. The app supports voice memos, image attachments and push notifications. Visage Ease Pro is designed as a thin client in a single module and allows to remotely access the images on a Visage 7 server. The communication between the mobile client and the server is encrypted. The user must authenticate himself with username and password. A connection can only be established, if the user has the appropriate permissions for using the mobile client. These permissions are configurable on the Visage 7 server.
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