# K243333: rTOP

- Pathway: 510(k) (Traditional)
- Applicant: Roclub GmbH
- Decided: Feb 4, 2025 after 103 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971684 (1997). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232744: syngo Virtual Cockpit (VB10A), Siemens Healthcare GmbH (2023) Summary page 5.

## Indications for 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).

Source page: https://510kreport.com/device/K243333
Methodology: https://510kreport.com/methodology