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510(k) Data Aggregation

    K Number
    K123575
    Device Name
    MAMMOWORKSTATION
    Manufacturer
    IMAGE DIAGNOST INTERNATIONAL GMBH
    Date Cleared
    2013-02-19

    (91 days)

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

    IMAGE DIAGNOST INTERNATIONAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images. It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. Mammo Workstation is designed to give easy and economic access to and display of multimodality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates. Mammo Workstation supports teleradiology and teleconferencing providing access to multimodality softcopy images and structured reports in multiple locations within and outside the hospital. Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography. All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.
    Device Description
    The Mammo Workstation is a medical image review workstation software for diagnostic and screening mammography. Mammoworkstation has the capability to review Digital Breast Tomosynthesis (DBT) images that are compatible with DICOM Breast Tomosynthesis Image Storage. It is a software product.
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    K Number
    K081630
    Device Name
    MAMMO WORKSTATION
    Manufacturer
    IMAGE DIAGNOST INTERNATIONAL GMBH
    Date Cleared
    2008-07-29

    (48 days)

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

    IMAGE DIAGNOST INTERNATIONAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images. It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. MammoWorkstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates. MammoWorkstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital. Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
    Device Description
    The MammoWorkstation is a medical image review workstation software for diagnostic and screening mammography. It is a software product. The product consists of features that allow the qualified medical professional to review patient medical images and to apply tools to cover the relevant aspects of an efficient review workflow. In addition, the system supports creation of report documents.
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