uOmniscan

uOmniscan is software for real-time remote communication and control of medical imaging devices, primarily MR scanners. It allows remote experts and on-site technicians to collaborate using read-only or full-control access, video, audio, and text chat. The device supports remote scan initiation for MR scanners and is used for training and operational support; images viewed remotely are not for diagnostic use.

uOmniscan is a PC-based, vendor-neutral software solution requiring standard computer and network hardware plus a KVM switch for third-party scanner connections. It matches the predicate device (syngo Virtual Cockpit VB10A) in user interface (keyboard, mouse, video), communication features (screen sharing, video, audio calls, chat), accessibility modes (read-only and full control), MR modality support, and remote scan initiation capability. Both are software-only solutions; the onsite technologist retains patient/scanner support oversight during acquisition.

ISO 14971 (risk management for medical devices, 2019 edition), IEC 62304 (medical device software life cycle processes, 2015 edition), and IEC 82304-1 (health software general safety requirements, 2016 edition).

The device is substantially equivalent because it shares the same intended use (remote operation, assistance, and training for medical imaging devices), regulatory classification (Class II, product code LLZ, 21 CFR 892.2050), and technological design as the predicate. Both devices employ identical PC-based software architecture with KVM switch connectivity, support the same MR modality with remote scan initiation, and maintain the same safety principle that the onsite technologist oversees patient care. Verification and validation testing confirmed equivalent functionality in real-time communication, network status identification, and usability across user expertise levels, with no unacceptable residual use-related risks identified.