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510(k) Data Aggregation
K Number
K243333Device Name
rTOP
Manufacturer
Date Cleared
2025-02-04
(103 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
roclub GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, ...) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.
rTOP is not indicated for any specific disease, or condition.
rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Device Description
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.
In addition to enabling remote access and control of the modality scanners, rTOP also supports common communication methods including live videos, audio calls and text chats amonq users.
rTOP allows full control of the connected devices, but for higher risk devices (e.g. LINACS, ...) rTOP only provides read-only access.
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