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510(k) Data Aggregation

    K Number
    K252477
    Date Cleared
    2025-09-09

    (33 days)

    Product Code
    Regulation Number
    892.1200
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis.

    Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations.

    The software application can be configured based on user needs.

    The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.

    Device Description

    Hybrid Viewer is a software application which provides 2D and 3D viewing, processing and analysis for nuclear medicine investigations.

    The studies can be loaded from patient browsers (e.g., GOLD) or PACS (Picture Archiving and Communication System).

    Hybrid Viewer provides general tools which include scrolling, zooming, panning, filtering, motion correction, fusion, registration, triangulation drawing regions of interest, synchronization of studies and performing mathematical operations. Specific investigation areas for Hybrid Viewer are Neurology (BRASS), Cardiology, Gastroenterology, Hepatology, Pneumology, Osteology and Nephrology.

    AI/ML Overview

    N/A

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