rTOP

rTOP is a telemedicine platform combining software and hardware that enables geographically distant technologists and radiologists to remotely operate, assist with, and monitor medical imaging and diagnostic devices. It provides secure video communication, screen sharing, and remote control capabilities (read-only or full access) for healthcare professionals to collaborate across multiple sites and train personnel on imaging equipment.

rTOP includes integrated hardware (roclub Connector with video splitter and mouse/keyboard emulation) plus software, whereas the predicate was software-only. rTOP uses a browser-based remote operator interface (OS-independent) versus the predicate's Windows requirement. rTOP supports dual monitors and has latency up to 100 ms with warnings, versus the predicate's ≤30–60 ms. rTOP uses WebRTC and HTTPS/UDP protocols; the predicate used VNC over TCP. Both are vendor-neutral and support read-only and full-access modes.

IEC 60601-1 (electrical and mechanical safety) and IEC 60601-1-2 (electromagnetic compatibility). Also referenced: IEC 60601-2-64 (light ion beam medical electrical equipment safety).

rTOP is substantially equivalent because it has identical intended use and clinical characteristics to the predicate syngo Virtual Cockpit: both enable remote operation, assistance, review, monitoring, and training for medical imaging devices in healthcare facilities with identical user profiles and limitations. Although rTOP includes hardware and supports a slightly broader range of diagnostic devices (with therapeutic devices in read-only mode), this does not raise new safety or effectiveness questions because higher-risk devices are restricted to read-only access per IEC 60601-2-64 standards, matching predicate practice. The hardware integration actually improves safety by including electromagnetic compatibility testing (60601-1-2) that standard KVM switches lack. Performance testing demonstrates comparable latency and functionality to the predicate.