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    Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·March 5, 2014

    Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·February 26, 2014

    Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·December 12, 2012

    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·September 28, 2016

    PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·May 23, 2018

    Philips Expression MR200 MRI Patient Monitoring System

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·October 22, 2014

    Philips Expression MR200 MRI Patient Monitoring System.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·January 21, 2015

    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

    FDA Enforcement
    Class II ·Completed·Invivo Corporation·November 21, 2018

    Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·August 27, 2014

    Philips Expression MR200 MRI Patient Monitoring System Model 866120

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·October 8, 2014

    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·September 14, 2016

    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·September 7, 2016

    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·April 11, 2018

    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

    FDA Enforcement
    Class II ·Ongoing·Invivo Corporation·June 13, 2018

    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·September 26, 2018

    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·March 11, 2020

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·November 15, 2017

    Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·December 27, 2017