510(k) · Cleared
ClearedMonaco RTP System (6.3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Solutions AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Feb 19, 2026 as substantially equivalent to K223233 (Elekta Solutions AB, 2023) after a 237-day review. Its family tree reaches back 20 generations to 1991.
- Decided
- Feb 19, 2026
- Review
- 237 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K913770 (1991). 259 ancestors in all, the oldest K802809 (1981). No later device cites it as a predicate yet.
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 16 generations between
- 3 generations backK202789 Monaco Rtp SystemElekta Solutions AB · 2021
- 2 generations backK213787 Monaco RTP SystemElekta Solutions AB · 2022
- 1 generation backK223233 Monaco RTP SystemElekta Solutions AB · 2023
- This deviceK252002 Monaco RTP System (6.3)Elekta Solutions AB · 2026
Show all 20 generations
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 19 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 18 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 17 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 16 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 15 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 13 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 12 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 11 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 10 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 9 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 8 generations backK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- 7 generations backK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- 6 generations backK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- 5 generations backK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- 4 generations backK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- 3 generations backK202789 Monaco Rtp SystemElekta Solutions AB · 2021
- 2 generations backK213787 Monaco RTP SystemElekta Solutions AB · 2022
- 1 generation backK223233 Monaco RTP SystemElekta Solutions AB · 2023
- This deviceK252002 Monaco RTP System (6.3)Elekta Solutions AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −19 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −18 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −17 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −16 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −15 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −13 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −12 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −11 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −10 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −9 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −8 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| −7 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| −6 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| −5 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| −4 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| −3 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
| −2 | K213787 | Monaco RTP System | Elekta Solutions AB | 2022 | — |
| −1 | K223233 | Monaco RTP System | Elekta Solutions AB | 2023 | — |
| 0 (this device) | K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 9 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 20 | 0 |
| 2001 | 23 | 0 |
| 2002 | 16 | 0 |
| 2003 | 14 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K223233 | Monaco RTP SystemSummary page 5…21 CFR 892.5050 Product Code MUJ III. Predicate Device Predicate # K223233 Predicate Trade Name Monaco RTP System (6.2) Predicate Product Code… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 84 of the 259 ancestors have a recall of any class.
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. 2026, 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?
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:
• contouring
• image manipulation
• simulation
• image fusion
• plan optimization
• QA and plan review
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252002: Monaco RTP System (6.3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252002
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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