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    K Number
    K040915
    Device Name
    MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
    Manufacturer
    INVIVO RESEARCH, INC.
    Date Cleared
    2004-09-22

    (167 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K974581,K923189,K023195
    Why did this record match?
    Device Name :

    MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

    Device Description

    The 3150M Fiber-Optic Temperature option enables the measurement of a patient's surface temperature both safely and accurately during all MRI procedures. This option utilizes a fiber-optic cable for interface between the temperature sensor at the patient application site and the measuring device. With this scheme, light channeled through a fiber-optic cable is the medium of temperature measurement rather than electrical conductor based components. The fiber-optic cable is impervious to the RF energy present during MRI procedures, thus eliminating the possibility of heating.

    The Fiber-Optic Temperature option contains four items: 1) Re-usable fiber optic surface temperature sensor. 2) Disposable surface temperature sensor applicator for use on patients ranging from Neonatal (5 kilograms) to Adult. 3) Fiber optic connector on the outside of the 3150M. 4) Signal conditioner inside 3150M patient monitor.

    AI/ML Overview

    The provided text describes the Invivo Research Inc. Magnitude™ 3150M MRI Monitor, which monitors various parameters, including temperature. The focus of the performance testing summary in the document is on the specifications for the temperature option of the device.

    Here's the breakdown of the acceptance criteria and the study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document includes a table of specifications that serve as acceptance criteria for the temperature monitoring function of the device. The reported device performance is stated as conforming to these specifications.

    ParameterAcceptance Criteria (Specification)Reported Device Performance
    Temperature Range20 to 44°CConforms to specification
    Accuracy± 0.3°CConforms to specification
    Resolution± 0.1°CConforms to specification
    Time to Steady State
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