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510(k) Data Aggregation

    K Number
    K130707
    Device Name
    ISIRONA MAGELLAN
    Manufacturer
    Date Cleared
    2013-11-20

    (250 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISIRONA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
    Device Description
    iSirona Magellan, is an on-site messaging integration solution which forwards information about patient alarms and other medical-related events obtained from information sources such as patient monitors, ventilators, infusion pumps, etc. to the user. The user receives the information via selective remote devices such as centralized computer stations and mobile communication devices provided by third-party companies. iSirona Magellan utilizes the existing hospital network to process data and relay secondary notifications. It is not to be considered a primary alarming device. iSirona Magellan connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. The user configures iSirona Magellan to determine which information, including alarm notifications, is delivered to which users, iSirona Magellan then formats the data for wireless delivery to the centralized computer stations and mobile communication devices.
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