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K Number
K152330
Device Name
Expression MR400 MRI Patient Monitoring System
Manufacturer
INVIVO CORPORATION
Date Cleared
2015-12-23

(127 days)

Product Code
MWI
Regulation Number
870.2300
Type
Special
Panel
CV
Reference & Predicate Devices
K124061
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The Expression MR400 MRI Patient Monitoring System (Model MR400) is intended for use by healthcare professionals.

The Expression MR400 MRI Patient Monitoring System (Model MR400) provides monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive blood pressure (IBP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (02), and/or temperature.

Device Description

The Expression MR400 is a multi-parameter patient monitoring system used to monitor the vital signs of patients in an MRI magnet room and throughout an MRI suite. The MR400's software simultaneously processes and displays multiple parameters, waveforms, measurement numeric values and alarms. All patient information is provided on a wheeled cart which consists of a patient monitor with a touch screen display. The device is powered by either AC line power or its internal battery. The standard and optional parameters which can be monitored by the MR400 include:

  • Electrocardiogram (ECG)
  • Heart rate (HR, ECG and SPO2 derived) ●
  • Blood oxygen saturation/pulse oximetry (SPO2)
  • End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
  • Invasive blood pressure (IBP) (P1 and P2) ●
  • Anesthetic agents (AGENT) ●
    • o Desflurane (DES)
    • o Enflurane (ENF)
    • o Halothane (HAL)
    • o Isoflurane (ISO)
    • o Sevoflurane (SEV)
  • Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O ● and FiN2O)
  • Temperature (TEMP) ●
  • Non-invasive blood pressure (NIBP)
  • . Respiration rate (CO2-derived and/or bellows-derived)

The MR400 consists of the following key components:

  • Cart with touchscreen display ●
  • Wireless ECG module .
  • Wireless SpO2 module ●
  • Batteries for both the Cart and Wireless Modules ●
  • Battery charger ●
  • Power cord ●

Accessories to the MR400 are offered to accommodate various patient sizes-neonatal, infant, pediatric, adult, and large adult. Key accessories include:

  • . ECG lead cables and electrodes
  • SPO2 probes and clips ●
  • NIBP cuffs and hoses ●
  • IBP transducer
  • Temperature probe and sheath ●
  • Cannulas ●
  • Water traps ●
  • Chest pneumograph ●
  • Expression IP5 (optional secondary display for control room w/printer) ●
AI/ML Overview

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).