uMR Jupiter

The uMR Jupiter is a 5T superconducting magnetic resonance diagnostic device that produces cross-sectional and spectroscopic images to display internal anatomical structure and function of the head, body, and extremities. It is intended for patients weighing more than 20 kg and assists in clinical diagnosis when interpreted by trained physicians.

The proposed device maintains identical core specifications to the predicate: 5.0 Tesla superconducting magnet with 60 cm bore, 120 mT/m maximum gradient amplitude, 200 T/m/s slew rate, 8-channel RF transmit system with 210.794 MHz resonant frequency, and 96 receive channels. Modifications include two new RF coils (SuperFlex Large-24 and Foot & Ankle Coil-24), five new pulse sequences, and seven new software functions (EasyScan, EasyCrop, t-ACS, QScan, tFAST, DeepRecon, WFI) compared to the predicate.

IEC 60601 series (electrical safety and EMC), IEC 60601-2-33 (MR-specific safety), IEC 62464-1 (image quality parameters), NEMA MS standards (SNR, geometric distortion, uniformity, slice thickness, SAR, RF coil heating), ISO 10993 (biocompatibility), ISO 14971 (risk management), 21 CFR Part 820 (quality systems), and NEMA PS 3 DICOM standards.

The proposed device employs identical fundamental MR technology and basic operating principles as the predicate device with the same indications for use. New RF coils are functionally equivalent to existing coils—SuperFlex Large-24 is a larger variant of SuperFlex Small-24 for the same anatomical regions, and Foot & Ankle Coil-24 has established precedent in reference devices. New pulse sequences and software functions (which incorporate machine learning algorithms like t-ACS and DeepRecon) were validated through non-clinical testing including image quality assessment by board-certified radiologists, demonstrating they produce diagnostically equivalent or superior images without raising new safety concerns. Extensive performance testing on diverse patient populations confirmed the device meets clinical diagnostic requirements, establishing substantial equivalence despite these incremental enhancements.