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510(k) Data Aggregation

    K Number
    K202335
    Device Name
    Ambra ProViewer
    Date Cleared
    2020-09-04

    (18 days)

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

    Dicom Grid, Inc, dba Ambra Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ambra PACS software is intended for use as a primary 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. Ambra Pro Viewer, a component of Ambra PACS, displays, modifics and manages diagnostic quality DICOM images including 3D visualization and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for manmography Display. Not intended for diagnostic use on mobile devices.
    Device Description
    Ambra ProViewer, a component of Ambra PACS, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering functionality. It is designed to target standards-compliant, cross-platform web browsers with an underlying architecture built on top of ReactJS and Material-UI, as well as WebGL2 for advanced visualization tools. The Ambra ProViewer is designed to utilize modern web application APIs. Ambra PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
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