NIDO Baby Magnetic Resonance Imaging System
Jiangsu LiCi Medical Device Co., Ltd.The NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.
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. The system is applicable for neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.
Technology
The device uses a 0.35 Tesla permanent magnet with an open U-shaped structure and integrated transceive RF head coil designed specifically for neonatal and infant head imaging. It acquires 2D single-slice, multi-slice, and 3D volume brain images using various pulse sequences such as Spin Echo, Fast Spin Echo, and Diffusion-Weighted Imaging. The system includes gradient, RF, spectrometer, temperature control systems, and clinical imaging software.
Performance
The device underwent software verification and validation, image performance testing per NEMA standards, biocompatibility tests, electrical safety and EMC evaluation per IEC standards, specific absorption rate characterization, and cybersecurity testing, demonstrating that it meets all applicable international and FDA recognized standards to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/29/2024
3 months - 2
FDA Approval
12/23/2024
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