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510(k) Data Aggregation

    K Number
    K090785
    Device Name
    MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
    Manufacturer
    INVIVO CORP.
    Date Cleared
    2009-12-15

    (267 days)

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

    INVIVO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
    Device Description
    The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MR environment. The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.
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    K Number
    K052704
    Device Name
    MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
    Manufacturer
    INVIVO CORP.
    Date Cleared
    2005-11-03

    (36 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVIVO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
    Device Description
    Model BBD Breast Immobilization and Biopsy Device
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    K Number
    K052497
    Device Name
    NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
    Manufacturer
    INVIVO CORP.
    Date Cleared
    2005-10-12

    (30 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVIVO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician.
    Device Description
    Model NVA-127-16-A Neurovascular Array Coil
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    K Number
    K051512
    Device Name
    CAC-127-8 CARDOAC ARRAY COIL
    Manufacturer
    INVIVO CORP.
    Date Cleared
    2005-06-28

    (21 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVIVO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.
    Device Description
    Model CAC-127-8 Cardiac Array Coil
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