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510(k) Data Aggregation

    K Number
    K221065
    Device Name
    MediLab
    Manufacturer
    Sigma Scientific Services LLC
    Date Cleared
    2022-06-10

    (59 days)

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

    Sigma Scientific Services LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MediLab is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. MediLab is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediLab is not intended for diagnostic use on mobile devices. Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
    Device Description
    The MediLab is a DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediLab is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediLab enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.
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