Embrace Neonatal MRI System

The Embrace Neonatal MRI System is a 1 Tesla permanent magnet MRI device that produces axial, sagittal, coronal, and oblique images of the neonatal head. It is intended for use in hospital settings to image neonates with head circumference up to 38 cm and weight between 1 kg and 4.5 kg, providing diagnostic information when interpreted by a trained physician.

The subject device has identical hardware specifications to the predicate, including 1 Tesla permanent magnet, 150 mT/m gradient strength, 0.300 mSec rise time, and 184×260 mm bore opening. Revision E includes software enhancements for usability and strengthened cybersecurity, plus improvements to the patient bed for usability and serviceability.

NEMA MS 1, MS 2, MS 3, MS 4, MS 5, MS 12, and MS 14 for imaging and safety performance; IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60601-2-20, IEC 60601-1-6, and IEC 62304 for electromagnetic compatibility, electrical, mechanical, and thermal safety; ISO 10993-1 for biocompatibility assessment.

The subject device is substantially equivalent to the predicate because both have identical intended use, product codes, classification, hardware specifications, and materials. The differences—software enhancements and bed improvements—do not raise new safety or effectiveness questions, as demonstrated by verification and validation testing including NEMA and IEC standards compliance.