Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213057
    Device Name
    ExamVue Duo
    Manufacturer
    JPI Healthcare Co, Ltd.
    Date Cleared
    2022-02-18

    (149 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI Healthcare Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue Duo is not indicated for use in mammography.
    Device Description
    The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions. Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.
    Ask a Question

    Page 1 of 1