Ascent3T Neonatal Magnetic Resonance Imaging System
Eyas Medical Imaging, Inc.The Ascent3T Neonatal Magnetic Resonance Imaging System is a specialized MRI scanner designed for newborns and infants weighing up to 9kg. It produces detailed cross-sectional images of the head, body, or extremities, helping clinicians diagnose medical conditions in neonatal patients. Its compact and optimized design allows it to be placed near point-of-care, improving workflow and patient comfort.
Intended Use
The Ascent3T Neonatal Magnetic Resonance Imaging System is a whole-body magnetic resonance scanner designed for neonates and infants. It produces cross-sectional images of the internal structure of the head, body or extremities in any orientation, providing diagnostic information for trained physicians. It is suitable for neonates and infants weighing up to 9kg (19.8 lbs).
Technology
The device uses a 3.0 Tesla superconducting magnet with a 25cm patient bore, minimal helium capacity without a quench pipe, and an 80 mT/m gradient system with a 300 mT/m/ms slew rate per axis. It includes safety features such as real-time SAR monitoring, accommodates axial, sagittal, coronal, and oblique image orientations, and has a detachable, mobile patient table optimized for neonates and infants. It uses magnetic resonance principles to generate highly detailed anatomical images via excitation of atomic nuclei, processed by a computer.
Performance
Verification and validation testing, including signal-to-noise ratio, geometric distortion, image uniformity, and slice thickness, confirmed the system performs safely and effectively. Testing followed recognized consensus standards. Software verification and validation showed no new risks. Biocompatibility was confirmed. No clinical studies were required, as equivalence to predicate devices was demonstrated.
Predicate Devices
No predicate devices specified
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