ROCLUB GMBH

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• rTOP

  2025-02-04

  Roclub GmbH

GUDID#

• rTOP - roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times.The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.

  roclub GmbH

  2025-03-26