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510(k) Data Aggregation

    K Number
    K161918
    Device Name
    SREE MRI Transport Incubator
    Manufacturer
    ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
    Date Cleared
    2017-03-03

    (233 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure. The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
    Device Description
    The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply. The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment. The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry. A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.
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    K Number
    K113365
    Device Name
    INFANT ARRAY
    Manufacturer
    ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
    Date Cleared
    2012-03-29

    (135 days)

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

    ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infant Array is a receive-only RF coil, used for obtaining high resolution images and spectra of the infant brain, spine, heart, torso and extremity in GE, Siemens and Philips 1.5T and 3.0T magnetic resonance imaging systems and magnetic resonance compatible incubators. Indications for use are same as that for standard MR imaging and spectroscopy. The Infant Array when used in conjunction with GE, Siemens and Philips 1.5T and 3T MRI systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
    Device Description
    The Infant Array is a 20-element receive-only radio-frequency (RF) coil array well suited for routine and parallel imaging. The Infant Array (IA) consists of an Infant Head Spine Array (IHSA) and an anterior Cardiac section (CAR). The IHSA can be used alone for spine and brain examinations or in conjunction with the anterior cardiac section necessary for cardiac and torso MRI exams. The anterior cardiac section cannot be used alone. This anterior cardiac section is supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The plastic materials used are fire rated and have a high impact and tensile strength. The coil design facilitates scanning of low birth weight pre-term babies, term newborns and small infants with different body sizes and maximizes comfort and ease of use. 20 element, receive-only RF coil array. The Infant Array consists of two sections: infant head spine array (IHSA) and anterior cardiac section (CAR), which is positioned above the IHSA and supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment.
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