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510(k) Data Aggregation

    K Number
    K223501
    Device Name
    ViewFinder Software Version 1.1
    Manufacturer
    Date Cleared
    2023-04-21

    (151 days)

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

    Elaitra Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ViewFinder is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to support qualified interpreting physicians in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. ViewFinder provides visualization and image enhancement tools to aid a qualified interpreting physician in the review of digital breast tomosynthesis datasets. The qualified interpreting physician is responsible for making the diagnosis of the images presented.
    Device Description
    ViewFinder is software which displays two Digital Breast Tomosynthesis (DBT) views of the same breast and dynamically indicates correlated (matched) tissue. The benefit is that clinicians can compare matched tissue quickly and with less cognitive load. It works by simulating the tissue movements between Cranio-Caudal (CC) and Medio-Lateral Oblique (MLO) compressions and views for a gross approximation of tissue matching, followed by a second fine tuning using locked Artificial Intelligence (AI). Users operate the device by pointing the cursor at tissue in one view and ViewFinder indicates the matching tissue in the other view. ViewFinder is a standalone software application or can be integrated into medical image management and processing systems. ViewFinder is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of DBT. ViewFinder runs on a PC and can be used for digital breast tomosynthesis image review together with monitors cleared for mammography diagnostics.
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