NIDO Baby Magnetic Resonance Imaging System

The NIDO Baby Magnetic Resonance Imaging System is a specialized 0.35 Tesla MRI device designed for producing axial, sagittal, coronal, and oblique images of the neonatal and infant head. It is intended for use in medical facilities to help physicians diagnose brain abnormalities in patients with head circumference up to 50 cm and weight up to 15 kg.

The subject device uses a 0.35T permanent magnet with an open U-shaped structure, lower gradient strength (32 mT/m vs. 150 mT/m for Predicate 1), lower slew rate (107 T/m/s vs. 500 T/m/s), and supports an expanded patient population (up to 15 kg vs. 4.5 kg for Predicate 1). It incorporates a transceive RF head coil, standard pulse sequences (Spin Echo, Fast Spin Echo, FLAIR, DWI), and operates at 14.6-14.9 MHz resonance frequency.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33; ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23; NEMA MS-1, MS-2, MS-3, MS-4, MS-5, MS-8, MS-12; IEC 62304; FDA guidance on software in medical devices and cybersecurity management.

The subject device is substantially equivalent because it shares the same intended use (MRI for head imaging), intended patient population (neonatal/infant), and fundamental technology (magnetic resonance) as the predicates. Although technical specifications differ (lower field strength and gradient), these do not introduce new safety or effectiveness risks and do not alter suitability for the stated indications. The device passed all applicable safety, performance, and biocompatibility testing and does not present new issues compared to legally marketed predicates.