uOmnispace.MR

The uOmnispace.MR is a post-processing software solution for viewing, manipulating, evaluating, and analyzing MR medical images within healthcare institutions. It includes 17 specialized applications for analyzing different types of MR data, including brain perfusion, cardiac function, diffusion, spectroscopy, and vascular imaging.

The proposed device is substantially equivalent to the predicate device (K233186) in device classification, product code (QIH), and regulatory class (Class II). Key differences include six new applications (Cardiac Perfusion, Cardiac Viability, SWI+, Diffusion Analysis, Multiplex Analysis, and ASL) and enhanced features for Brain Perfusion; however, these use the same fundamental post-processing principles as predicate and reference devices.

NEMA PS 3.1–3.20 DICOM (2023e), ISO 14971 (risk management), IEC 62304 (software life cycle), FDA Cybersecurity guidance, and FDA Content of Premarket Submissions for Device Software Functions.

The proposed device is substantially equivalent because it shares the same intended use, device classification, and fundamental scientific technology as the predicate device. Comprehensive verification testing (ICC, clinical image evaluation, motion correction validation, parametric mapping accuracy) demonstrated that all new features and enhanced functions meet or exceed acceptance criteria and produce results comparable to predicate and reference devices.