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510(k) Data Aggregation

    K Number
    K242573
    Device Name
    NIDO Baby Magnetic Resonance Imaging System
    Date Cleared
    2024-12-23

    (116 days)

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

    Jiangsu LiCi Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIDO Baby Magnetic Resonance Imaging System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.
    Device Description
    The NIDO Baby Magnetic Resonance Imaging System, model LCM-MRI-3500-01A, is a specialized open-type MRI system designed for neonatal and infant head imaging. The system utilized a 0.35 Tesla (T) permanent magnet to acquire 2D single-slice, multi-slice, and 3D volume images of the brain. Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses strong magnetic fields, radio waves, and a computer to produce detailed images of the internal structures of the body. Unlike X-rays or CT scans, MRI does not use ionizing radiation. Instead, it relies on the magnetic properties of atoms in the body, particularly hydrogen atoms, which are abundant in water and fat. When a patient is placed inside the MRI machine, the powerful magnets that create a strong magnetic field around the patient causes hydrogen atoms in the body to align with the field. Once the hydrogen atoms are aligned, radio waves are sent into the body. These waves temporarily disrupt the alignment of the hydrogen atoms. When the radio waves are turned off, the hydrogen atoms return to their original alignment, emitting signals in the process. These signals are detected by the MRI machine and converted into detailed images of the body's internal structures. The NIDO Baby Magnetic Resonance Imaging System features a 0.35T permanent magnet with an open U-shaped structure, optimized for MR head imaging of neonatal and infant patients. Key components include the magnet system, gradient system, radio frequency (RF) system, spectrometer system, temperature control system and clinical imaging software. The system's gradient field strength is ≤32 mT/m with a slew rate of ≤107 T/m/s. Integrated transceive RF head coil also functions as a patient table, operating within a resonance frequency range of 14.6 MHz to 14.9 MHz is used to acquired MR images and to provide patient safety and comfort during scanning. The high-performance computer console is installed with clinical imaging software, which includes a variety of pulse sequences, such as Spin Echo, Fast Spin Echo, Fast Low Angle Shot Gradient Echo, Fluid-Attenuated Inversion Recovery and Diffusion-Weighted Imaging for Proton Density, T1 weighted, T2 weighted and Diffusion imaging.
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