510(k) · Cleared
ClearedImagingRing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medphoton GmbH · IYE Accelerator, Linear, Medical
Cleared on Dec 8, 2016 as substantially equivalent to K131965 (Elekta Limited, 2013) and 1 other predicate after a 202-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Dec 8, 2016
- Review
- 202 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K926449 (1995). 37 ancestors in all, the oldest K864886 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 5 generations between
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK161400 ImagingRing SystemMedphoton GmbH · 2016
- Descendant · cites it directly · 0 of its ownK191267 ImagingRing System on RailsMedphoton GmbH · 2019
Show all 9 generations
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 8 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 7 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 6 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 5 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 4 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK161400 ImagingRing SystemMedphoton GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K191267ImagingRing System on RailsMedphoton GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −8 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −7 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −6 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −5 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −4 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −3 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −2 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −1 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| 0 (this device) | K161400 | ImagingRing System | Medphoton GmbH | 2016 | — |
| +1 | K191267 | ImagingRing System on Rails | Medphoton GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131965 | XVI R5.0Summary page 6…o. Predicate devices: 1. Primary Predicate Device Trade Name: XVI R5.0 Applicant: Elekta Limited 510(k) No.: K131965 2. Device Trade Name: kVue™ IGRT Couch top Applicant: Aquaplast/Qfix 510(k) No.:… | 2013 |
| * | K060671 | Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, VariousSummary page 6…K131965 2. Device Trade Name: kVue™ IGRT Couch top Applicant: Aquaplast/Qfix 510(k) No.: K060671 The ImagingRing System is considered substantial equivalent to the Elekta XVI R5.0 (K131965) and the kVue™ IGRT Couch top (K06… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191267 | ImagingRing System on Rails | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 24 of the 37 ancestors have a recall of any class.
- Of its descendants, K191267 (Medphoton GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131965.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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…
Read the full statement (309 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161400: ImagingRing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161400
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026