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510(k) Data Aggregation

    K Number
    K123426
    Device Name
    MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
    Date Cleared
    2013-03-01

    (114 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 video-conferencing 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. The MedicVOD system is intended as a radiological image processing system that allows for the capture, transfer, display, storage, and digital processing of medical images.
    Device Description
    The MedicVOD System is a video system enabling medical teams to document, record and broadcast live medical procedures in real time. Its four components are: - The mediCAST station, attached to the imaging device in an operating theater - The mediShow application, a real-time monitoring application, displaying sessions from all currently active mediCAST stations - The mediSearch video archive search and edit application - The MedicVOD Server which is a central storage system (CSS) for archival of all mediCAST sessions The MedicVOD 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 which may be used by other 300 party applications for purposes such as statistical analysis of data usage and/or user operation and report production, and - Ability to view/review videos from any mediShow location at any time The mediCAST station is capable of capturing and broadcasting a video stream in real time. MediCAST station captures and stores video and still images locally, and in parallel, uploads the capture images and video streams to the MedicVOD server. The mediCAST station 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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