# K161400: ImagingRing System

- Pathway: 510(k) (Traditional)
- Applicant: Medphoton GmbH
- Decided: Dec 8, 2016 after 202 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: 9 generations back to K926449 (1995). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131965: XVI R5.0, Elekta Limited (2013) Summary page 6.
- K060671: Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various, Wfr/Aquaplast Corp. (2006) Summary page 6.

## Most influential descendants
- K191267: ImagingRing System on Rails (2019), 0 descendants of its own

## Indications for use
The ImagingRing System (IRS) is an X-ray device consisting of (1) imaging components, supports and software and (2) patient support structure (couch top), designed to support patient localization in the Couch Coordinate System (CCS) 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. IRS 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. IRS provides 2D planar imaging (including streaming and recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, and is intended to 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, IRS 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) in order to receive commands and data from and provide information to (e.g., receiving command from RTCS to start an image acquisition and providing image data to RTCS for the purpose to calculate and execute the patient (re)-positioning vector externally in the third party system) « interfaced with a Patient Positioning Systems (PPS), like - but not limited to - a robotic multi-axis system, to allow the calculated (re)-positioning vector to be applied with respect to Coordinate Systems the treatment delivery unit relates to.

Source page: https://510kreport.com/device/K161400
Methodology: https://510kreport.com/methodology