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.

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