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510(k) Data Aggregation

    K Number
    K223660
    Device Name
    SaintView
    Manufacturer
    Date Cleared
    2023-08-14

    (251 days)

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

    Inviz Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SaintView is a software device that receives medical images and data from various images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists. nurses, and medical technicians.
    Device Description
    SaintView is a product for checking, analyzing, recording and storing images of medical images in hospitals. It has functions such as storing, transmitting, viewing, zooming in, reducing, moving and rotating medical images, as well as measuring length to aid in reading, and displaying various tools and reference positions. This product has a worklist for ease of reading, support for high-resolution medical monitors, and software division function for large monitors. In addition, it supports DICOM standard so that DICOM video can be checked in the viewer, and DICOM standard is also supported for video reception, transmission, CD creation, and printing.
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