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510(k) Data Aggregation

    K Number
    K142337
    Device Name
    Blackford Analysis Registration Product Family
    Date Cleared
    2015-03-19

    (210 days)

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

    BLACKFORD ANALYSIS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Blackford Registration Product Family consists of two components: 1. A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration. 2. A localizer tool that works across studies, or series in the same study within a different frame of reference. The first intended clinical use, when reading studies, is to aid navigation through, and comparative interpretation of, a target series with respect to a source series will be within a current study and the target series will be within a prior study. However they may also be within the same study but have a different frame of reference. Aiding navigation may include, but is not limited to, indicating corresponding anatomical locations, synchronized scrolling, matching orientations and/or reference lines in reformatted series and fusing two images from source and target series. The second clinical use is to aid presentation of change between cross-sectional radiographic studies to clinical colleagues and patients. Registration-aided interpretation of images should be carried out by a suitably qualified physician, who will base their diagnoses on training and protocols that do not necessarily rely on registration for navigation.
    Device Description
    The Blackford Registration Product Family consists of two components: 1. A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration. 2. A localizer tool that works across studies, or series in the same study within a different frame of reference.
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