510(k) · Cleared
ClearedRadiance V2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmv Soluciones Globales Internet S.A.U. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 31, 2014 as substantially equivalent to K112060 (Gmv Aerospace and Defence S.A., 2012) and 2 other predicates after a 65-day review. Its family tree reaches back 10 generations to 1986. 5 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 65 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K864210 (1986). 61 ancestors in all, the oldest K852907 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 6 generations between
- 3 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 2 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 1 generation backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- This deviceK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · cites it directly · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 2 generations on · 3 of its ownK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
- Descendant · 3 generations on · 0 of its ownK233236 Radiance V5Gmv Soluciones Globales Internet S.A.U. · 2024
- Descendant · 3 generations on · 0 of its ownK182665 Sensus TPS WorkstationSensus Healthcare, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK180308 PreludeMedcom GmbH · 2018
Show all 10 generations
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 9 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 8 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 7 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 6 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 5 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 4 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 3 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 2 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 1 generation backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- This deviceK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
Most influential descendants
Showing 5 of 5 · See all- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · cites it directly4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 2 generations on3descendants
- K233236Radiance V5Gmv Soluciones Globales Internet S.A.U. · 2024 · 3 generations on0descendants
- K182665Sensus TPS WorkstationSensus Healthcare, Inc. · 2019 · 3 generations on0descendants
- K180308PreludeMedcom GmbH · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −9 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −8 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −7 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −6 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −5 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −4 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| −3 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| −2 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| −1 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| 0 (this device) | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +1 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +2 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
| +3 | K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | 2024 | — |
| +3 | K182665 | Sensus TPS Workstation | Sensus Healthcare, Inc. | 2019 | — |
| +3 | K180308 | Prelude | Medcom GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K112060 | RadianceSummary page 1…re Classification Name. Medical charged-particle radiation therapy sy stem Number & 21 CER 892.5050 Product Code: M U.1 Predicate Devices: K 112060 Radiance cleared 01/06/2012 K 12 1653 INTRABEAM SYSTEM W… | 2012 |
| * | K121653 | Intrabeam System with Intrabeam Spherical ApplicatorsSummary page 1…ER 892.5050 Product Code: M U.1 Predicate Devices: K 112060 Radiance cleared 01/06/2012 K 12 1653 INTRABEAM SYSTEM WITH INTRABEAM SIPHERICAL APPLICATORS… | 2012 |
| * | K102011 | Eclipse Treatment Planning SystemSummary page 1…ABEAM SYSTEM WITH INTRABEAM SIPHERICAL APPLICATORS Cleared 12/27/2012 K 102011 Eclipse Treatment Planning Systemn Cleared 09/03/20 10 Device Description Radian… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153368 | Radiance V3 | 2016 | 4 |
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 28 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 15 of the 61 ancestors have a recall of any class.
- Of its descendants, K153368 (Gmv Soluciones Globales Internet S.A.U., 2016) has gone furthest, with 4 descendants of its own.
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. 2014, 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 V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
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 V2 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/K133655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133655: Radiance V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133655
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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