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510(k) Data Aggregation

    K Number
    K240724
    Device Name
    SynthVISION 1.0.0
    Manufacturer
    Synthesis Health Intelligence Inc
    Date Cleared
    2024-08-08

    (143 days)

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

    Synthesis Health Intelligence Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.
    Device Description
    SynthVISION is a medical imaging viewing software used with off-the-shelf workstation hardware and web browsers for the 2D & 3D diagnostic visualization of DICOM and non-DICOM medical images by intended users such as trained radiologists, technologists and all others involved in the patient's care. SynthVISION consists of configurable software-only modules that display and process DICOM and non-DICOM images and associated medical information to aid in the day-to-day operations and workflow of imaging healthcare professionals, clinicians and other healthcare practitioners. SynthVISION has the following primary features and functions - - Zero-footprint medical image upload, transfer, and display of medical images between facilities - Easy access to images for all participants in the healthcare process, including radiologists, physicians, nurses and others who participate in patient care - Serves as information and data management system for DICOM and non-DICOM medical images - Industry-standard tools for image manipulation, annotation and measurement ● - Metadata information and orientation labels display - . Advanced image manipulation functions like view synchronization across series, MIP and MPR - Advanced image processing filters - Encrypted transmission of medical images through secured networks - Encrypted storage of medical images - . HIPAA-compliant data management, including centralized storage of user activities via audit trails.
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