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…
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.
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.
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| 1 | Withdrawn |
Same 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
| 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.