rTOP

rTOP is a medical image teleoperation platform made up of software and hardware. The FDA filing describes remote operation, assistance, review, monitoring and standardization of medical…

Registry build 21.09.26

rTOP is a medical image teleoperation platform made up of software and hardware. The FDA filing describes remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices.

The system allows read-only or full access control to connected devices and is also intended for training personnel who work with medical imaging devices. The filing describes remote assistance by geographically distant technologists or radiologists.

Listed Item

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.

Remote Operation and Assistance

The platform provides a remote connection between local and remote operators. The FDA summary describes a browser-based remote operator application and a local operator connection through the roclub connector.

16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LLZ
Manufacturer City Province Registered as Device types
Shantou Institute OF Ultrasonic Instruments Co., Ltd. Shantou Guangdong Contract manufacturer 8
iRay Imaging Technology (Haining) Limited Haining Zhejiang Contract manufacturer 6
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological

Record

Regulatory record for rTOP
Listed by Roclub Gmbh, Germany
FDA product code LLZ
Device type System, Image Processing, Radiological
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Specification developer, Manufacturer
510(k) K243333
Record published 2025-03-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2025-03-26

Catalogue Numbers

Catalogue numbers for rTOP
Catalogue number Size Status
1 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imagegrid Radiology Viewer System Candelis, Inc. 173
Tims System Foresight Imaging, LLC 159
System, Image Processing, Radiological Biomet Microfixation 146
RamSoft Ramsoft, Inc. 65
Joints Medstrat 62
OrthoView Meridian Technique Ltd 54
IPS KLS-Martin L.P. 48
NovaPACS Novarad Corp. 42
PointCloud Knee Instruments Unik Orthopedics, Inc 34
DTX Studio™ Clinic Nobel Biocare AB 34
Eaglesoft Patterson Technology Center 33
Medtronic Navigation Medtronic Navigation, Inc. 26

Showing 12 of 1,109. All products under System, Image Processing, Radiological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243333 2025-02-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer