TechLive

TechLive is a software application that enables remote access to medical imaging devices (ultrasound, MRI, CT, PET/CT) for real-time image acquisition, assistance, review, monitoring, and training of healthcare personnel. It provides secure remote control and collaboration features via audio/video connection but is explicitly not intended for diagnostic use.

TechLive uses WebRTC over HTTPS for connection protocols compared to the predicate's HTTPS over TCP. It supports a subset of radiological devices (excluding radiotherapeutic devices) versus the predicate's broader support. Communication relies on USB cameras for live video and audio without a chat function, versus the predicate's chat capability. Both provide remote image acquisition with vendor-neutral functionality across multiple imaging modalities.

ISO 14971:2019 (Risk Management), IEC 62304:2015 (Medical Device Software Life Cycles), IEC 82304-1 (Health Software General Requirements), FDA Guidance on Device Software Functions (June 2023), and FDA Guidance on Cybersecurity in Medical Devices (September 2023).

TechLive and the predicate (Syngo Virtual Cockpit) share identical indications for use, intended users (remote operators and IT administrators), and intended environment (healthcare facilities). Both are vendor-neutral software for remote imaging support and standardization. The minor differences—WebRTC versus HTTPS/TCP protocols, exclusion of radiotherapeutic devices, and communication tool variations—do not raise new safety or effectiveness questions because verification and validation testing demonstrated the subject device meets all performance specifications and user needs equivalent to the predicate.