510(k) · Cleared
ClearedRadiance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmv Aerospace and Defence S.A. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 6, 2012 as substantially equivalent to K100552 (Raysearch Laboratories AB, 2010) after a 171-day review. Its family tree reaches back 6 generations to 1987. 6 later devices descend from it.
- Decided
- Jan 6, 2012
- Review
- 171 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K862643 (1987). 13 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 5 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 4 generations backK031349 OTP 1.2Nucletron Corp. · 2003
- 3 generations backK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- 2 generations backK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- 1 generation backK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- This deviceK112060 RadianceGmv Aerospace and Defence S.A. · 2012
- Descendant · cites it directly · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 2 generations on · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 3 generations on · 3 of its ownK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
- Descendant · 4 generations on · 0 of its ownK233236 Radiance V5Gmv Soluciones Globales Internet S.A.U. · 2024
- Descendant · 4 generations on · 0 of its ownK182665 Sensus TPS WorkstationSensus Healthcare, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · cites it directly5descendants
- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · 2 generations on4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 3 generations on3descendants
- K233236Radiance V5Gmv Soluciones Globales Internet S.A.U. · 2024 · 4 generations on0descendants
- K182665Sensus TPS WorkstationSensus Healthcare, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −5 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −4 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| −3 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| −2 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| −1 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| 0 (this device) | K112060 | Radiance | Gmv Aerospace and Defence S.A. | 2012 | — |
| +1 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +2 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +3 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
| +4 | K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | 2024 | — |
| +4 | K182665 | Sensus TPS Workstation | Sensus Healthcare, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K100552 | Raystation Version 1.0Summary page 1…sification Name, Medical charged-particle radiation therapy system Number & 21 CFR 892.5050 Product Code: MUJ Predicate Devices: RayStation K100552 cleared 12 March 2010 Device Description radiance is a treatment planning system, that, is, a software and Statement of… | 2010 |
| † | K102011 | Eclipse Treatment Planning System | 2010 |
| † | K990209 | NOVAC7 | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133655 | Radiance V2 | 2014 | 5 |
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 25 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K133655 (Gmv Soluciones Globales Internet S.A.U., 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K100552.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of radiance shall be clinically qualified radiation therapy staff trained in using the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112060: Radiance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112060
Report an extraction error
Are you the manufacturer?
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