TechLive
DeepHealth, Inc.TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.
Intended Use
TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use.
Technology
TechLive operates as a vendor-neutral software enabling remote access to imaging device consoles via secure connections, streaming live audio, video, keyboard, and mouse controls. It supports multiple modalities including US, MRI, CT, and PET/CT and offers 'view' and 'control' modes for remote assistance or image acquisition. TechLive uses WebRTC over HTTPS for communication to ensure security and seamless collaboration among healthcare professionals.
Performance
No clinical testing was conducted. Non-clinical performance testing including verification and validation were completed according to applicable FDA-recognized standards (ISO 14971, IEC 62304, IEC 82304-1) and FDA guidances for device software and cybersecurity. Usability studies (formative and summative) confirmed safe and effective use. Vendor-neutral multi-vendor interoperability testing confirmed seamless operation across various imaging device types. Overall, testing supports safety and effectiveness and substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
6 months - 2
FDA Approval
6/5/2025
Other devices from DeepHealth, Inc.
- Saige-Density (2.5.0)2024 • 510K
- Saige-Dx (3.1.0)2024 • 510K
- Saige-Dx2024 • 510K
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