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Intended Use

CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screen sharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.

Technology

CT Collaboration Live is a software application integrated into Philips CT X-Ray CT 5300 Systems enabling two-way communication of text, voice, image, and video between a CT system operator and a remote user on a Windows device. It includes features for peer consultation, system-level remote sharing and operation, access to live image feed, and remote expert consultation. Remote control is granted by the local operator to one qualified remote user at a time and may be revoked at any time.

Performance

Non-clinical software verification testing was performed, demonstrating compliance with international and FDA-recognized standards. Design verification, risk analysis, and mitigation testing verified that the software meets design input requirements. No clinical study was required as equivalence to predicate device was demonstrated in indications for use, technology, and safety/effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/6/2024

    3 months
  • 2

    FDA Approval

    11/18/2024

Other devices from Philips Healthcare (Suzhou) Co., Ltd

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