# K191267: ImagingRing System on Rails

- Pathway: 510(k) (Traditional)
- Applicant: Medphoton GmbH
- Decided: Aug 1, 2019 after 83 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K926449 (1995). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161400: ImagingRing System, Medphoton GmbH (2016) Summary page 6.

## Indications for use
The TmagingRing System on rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of imaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents. IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support patient positioning, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement. With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) — receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data, providing input for third party RTCS for repositioning of the patient).

Source page: https://510kreport.com/device/K191267
Methodology: https://510kreport.com/methodology