Intended Use

ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi vendor solution allowing view only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected medical imaging devices.

Technology

ROCC Console is a software device that operates as part of the Radiology Operations Command Center (ROCC) system, which is a cloud-based solution connecting expert radiology users at a remote command center with onsite technologists operating MR/CT scanners. It supports multiple connection methods (KVM over TCP, VNC) to allow remote access or view-only functionality, and includes a Protocol Management mode for protocol updates and harmonization without onsite technologist participation.

Performance

Verification and validation activities including software verification and validation documents support the performance and safety of the ROCC Console, demonstrating it is as safe and effective as the predicate device (syngo Virtual Cockpit VB10A).

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/23/2024

    2 months
  • 2

    FDA Approval

    10/24/2024

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