510(k) · Cleared
Recalled · Class II · 2021Monaco RTP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 29, 2019 as substantially equivalent to K183037 (Elekta, Inc., 2018) after a 56-day review. Its family tree reaches back 16 generations to 1991. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 29, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 16 generations to K913770 (1991). 213 ancestors in all, the oldest K864886 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations between
- 3 generations backK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- 2 generations backK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- This deviceK190178 Monaco RTP SystemElekta, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
- Descendant · 2 generations on · 2 of its ownK213787 Monaco RTP SystemElekta Solutions AB · 2022
- Descendant · 3 generations on · 1 of its ownK223233 Monaco RTP SystemElekta Solutions AB · 2023
- Descendant · 4 generations on · 0 of its ownK252002 Monaco RTP System (6.3)Elekta Solutions AB · 2026
Show all 16 generations
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 14 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 13 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 12 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 11 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 9 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 6 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 5 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 4 generations backK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- 3 generations backK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- 2 generations backK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- This deviceK190178 Monaco RTP SystemElekta, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · cites it directly3descendants
- K213787Monaco RTP SystemElekta Solutions AB · 2022 · 2 generations on2descendants
- K223233Monaco RTP SystemElekta Solutions AB · 2023 · 3 generations on1descendant
- K252002Monaco RTP System (6.3)Elekta Solutions AB · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −15 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −14 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −13 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −12 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −11 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −9 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −6 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −5 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −4 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| −3 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| −2 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| −1 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| 0 (this device) | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | — |
| +1 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
| +2 | K213787 | Monaco RTP System | Elekta Solutions AB | 2022 | — |
| +3 | K223233 | Monaco RTP System | Elekta Solutions AB | 2023 | — |
| +4 | K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 20 | 0 |
| 2001 | 18 | 0 |
| 2002 | 14 | 0 |
| 2003 | 14 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K183037 | Monaco RTP SystemSummary page 5…rsonal Data PREDICATE DEVICE INFORMATION The Monaco RTP System with new features is substantially equivalent to the previously cleared Monaco RTP System (K183037), which is actively marketed in the United States. The updated Monaco is substantially equivalent in intended use and safety and… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202789 | Monaco Rtp System | 2021 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2021 | Class II | Z-2563-2021 | Software design | Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set. |
| Jul 26, 2021 | Class II | Z-2406-2021 | Under Investigation by firm | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. |
| Nov 22, 2019 | Class II | Z-0670-2020 | Software Design Change | Monaco is using the incorrect energy when optimizing and calculating dose. |
| Sep 4, 2019 | Class II | Z-2561-2019 | Software design | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. |
| Aug 23, 2019 | Class II | Z-2409-2019 | Device Design | Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 68 of the 213 ancestors have a recall of any class.
- Of its descendants, K202789 (Elekta Solutions AB, 2021) has gone furthest, with 3 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. 2019, 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 and electron 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/K190178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190178: Monaco RTP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190178
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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