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510(k) Data Aggregation

    K Number
    K231360
    Device Name
    Ambra PACS
    Date Cleared
    2023-06-07

    (28 days)

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

    DICOM Grid 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, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality. Lossy compressed mammographic images and digitized film screen mages must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography Display. Not intended for diagnostic use on mobile devices.
    Device Description
    Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images and reporting for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and supplementary information. Ambra PACS is considered a 'Continuous Use' device is compliant with HIPAA 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. Ambra PACS provides common diagnostic and analytic radiology functionality. Specifically, Ambra PACS enables: - Real-time viewing and management of DICOM images for diagnostic, clinical, research and education purposes; - Ingestion and normalization of DICOM content for review and archiving; - Electronic distribution and secure storage of images; - Off-site viewing and reporting (distance education, tele-diagnosis). Ambra ProViewer, a component of Ambra PACS, displays, modifies, 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 mammography display.
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