uMR Jupiter

“uMR Jupiter is a 5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore and 8 channel RF transmit system. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. uMR Jupiter is designed to conform to NEMA and DICOM standards. The modification performed on the uMR Jupiter in this submission is due to the following changes that include: (4) Addition of function: EasyScan, EasyCrop, t-ACS, QScan, tFAST, DeepRecon and WFI.”

“The WFI (Water-Fat Imaging) is a hybrid water-fat separation algorithm, which utilizes deep learning to improve the stability of conventional algorithms. To overcome this challenge, an artificial intelligence (AI) network has been trained to provide a more accurate initialization for the RIPE algorithm. To accommodate various clinical needs, WFI provides a user preference setting with three modes (i.e., default mode: conventional RIPE-based WFI, standard mode: hybrid Al-assisted RIPE-based WFI, and fast mode: AI-based WFI). t-ACS (temporal AI-assisted Compressed Sensing) is a dynamic magnetic resonance (MR) imaging technique which combines traditional Compressed Sensing algorithm with deep learning priors. t-ACS technique reconstructs multi-phase MR data and outputs multi-phase images. DeepRecon is a deep-learning based image processing algorithm for intelligent image de-noising and K-space-interpolation based image super-resolution. EasyFACT workflow, based on the FACT sequence, automatically places the ROI (Regions of Interest) of 5 suitable locations on the liver and performs numerical statistics of quantitative values (FF and R2*), including mean, maximum, minimum and other information, and outputs online reporting. EasyScan is a workflow feature that automatically locates slice groups. This function is based on deep learning algorithms, which identify, locate or segment specific tissue structures in images, and calculate the position and orientation of slice groups to achieve automatic placement of slice groups. EasyCrop is a function that enables automatic cropping of images scanned with the MRA images to simplify the workflow, which allows users to obtain interference-free MIP images and automatically rotated MIP images with different angles when the scan is completed and images are generated.”

“To accommodate various clinical needs, WFI provides a user preference setting with three modes (i.e., default mode: conventional RIPE-based WFI, standard mode: hybrid Al-assisted RIPE-based WFI, and fast mode: AI-based WFI).”

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”