Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K083539
    Device Name
    INFANT CARDIAC ARRAY
    Manufacturer
    ADVANCED IMAGING RESEARCH, INC.
    Date Cleared
    2009-04-03

    (126 days)

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

    ADVANCED IMAGING RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K083541
    Device Name
    NEONATE HEAD AND BODY COILS
    Manufacturer
    ADVANCED IMAGING RESEARCH, INC.
    Date Cleared
    2009-02-24

    (88 days)

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

    ADVANCED IMAGING RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neonate (Head, Body) Coil is a quadrature transmit/receive coil used for obtaining diagnostic images and spectra of the (pre- and term) infant head in 1,5 and 3,0 Tesla General Electric, Siemens Medical Solutions and Philips Medical Systems' Magnetic Resonance Imaging (MRI) scanners and magnetic resonance compatible incubator systems. Indications for use are same as that for standard MR imaging. The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
    Device Description
    The Neonate (Head, Body) Coil is a 12 element quadrature, transmit/receive coil. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use.
    Ask a Question
    K Number
    K023929
    Device Name
    MAGNETIC RESONANCE DIAGNOSTIC DEVICE
    Manufacturer
    ADVANCED IMAGING RESEARCH, INC.
    Date Cleared
    2003-02-21

    (88 days)

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

    ADVANCED IMAGING RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RF coils when used in conjunction with the MRI systems or RF coils when used with the incubator system and both the incubator and RF coils used in conjunction with the MRI systems provide imaging of the adult head, extremity, neonate head and body. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
    Device Description
    Device function is similar to the predicate devices, and in general any RF coil for MRI. Advanced Imaging Research, Inc. intends to introduce Quadrature, Volume Coils for adult and pediatric MR. Specifically, Improved Adult Head coils, and Neonate Head and Body Volume coils safe for use with MRI compatible incubator systems are enclosed. Our Improved Adult Head Coils provide enhanced signal-to-noise ratio (SNR), a high degree of RF homogeneity and is "open" to alleviate patient claustrophobia. Our Neonate Coils are intended to scan pre- and term neonates and are designed for use with MR compatible incubator systems. The Neonate Head coil is intended to scan the newborn brain, whereas the Neonate Body coil is intended to scan the major organs (heart, spine, abdomen, pelvis etc.) in the torso and extremities.
    Ask a Question

    Page 1 of 1