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510(k) Data Aggregation

    K Number
    K151737
    Device Name
    MedicVOD System
    Date Cleared
    2016-02-25

    (244 days)

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

    Orpheus Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with videoconferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.
    Device Description
    Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components: mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera. mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time. mediCast Mobile App - a smart phone application for uploading medical images and videos. mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video. mediShow a viewer for real-time broadcasting from a mediCast System. mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast. mediWeb - a web based application that provides access to the mediSearch and mediShow applications. The MedicVOD System key features include: Digital recording of medical procedures streamed directly to on-site server for storage and retrieval, Live broadcast of a medical procedure to an unlimited number of viewers, Archiving of video assets to a controlled storage resource, Data fetching with dynamic categories for statistical analysis and multiple report production, and Ability to view/review videos. The mediCAST box is capable of capturing and broadcasting a video stream in real time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box uploads the videos and images when there is communication with the MedicVOD server. The mediSearch application provides the ability to search within the MedicVOD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities. The mediShow application automatically connects into the MedicVOD server and displays currently active sessions or procedures captured by any mediCAST station on the local network.
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