uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.
Intended Use
uOmniscan is a software application for providing real-time communication between remote and local users, providing remote read-only or fully controlled access to connected medical imaging devices, including the ability to remotely initiate MR scans. It is also used for training medical personnel in the use of medical imaging devices. It is a vendor-neutral solution. Access must be authorized by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.
Technology
uOmniscan is a software-only solution that enables remote interaction between on-site technicians and remote experts connected via hospital networks. It establishes connections through application, KVM switch, or proprietary access tools, allowing full or read-only mode control of imaging devices, including initiating MR scans. It supports video, audio calls, and chat, facilitating collaborative workflow and training while ensuring images viewed remotely are not for diagnostic purposes.
Performance
Performance testing included software verification and validation to ensure safety and efficacy, including real-time communication establishment, control sessions via KVM and proprietary tools, network condition evaluation, and usability studies involving expert and user feedback. No clinical or animal studies were required. Software and risk management standards (ISO 14971, IEC 62304, IEC 82304-1) were applied. Electrical safety and EMC testing were not applicable.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2024
6 months - 2
FDA Approval
6/17/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uMR Ultra2025 • 510K
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2025 • 510K
- uMR 6802025 • 510K
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