510(k) · Cleared
Recalled · Class II · 2023Monaco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impac Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 7, 2015 as substantially equivalent to K132971 (Impac Medical Systems, Inc., 2013) and 1 other predicate after a 60-day review. Its family tree reaches back 14 generations to 1991. 6 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 7, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 14 generations to K913770 (1991). 184 ancestors in all, the oldest K862643 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 2 generations backK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- 1 generation backK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- This deviceK151233 MonacoImpac Medical Systems, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
- Descendant · 4 generations on · 2 of its ownK213787 Monaco RTP SystemElekta Solutions AB · 2022
- Descendant · 5 generations on · 1 of its ownK223233 Monaco RTP SystemElekta Solutions AB · 2023
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 12 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 11 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 10 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 9 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 7 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 4 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 3 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 2 generations backK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- 1 generation backK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- This deviceK151233 MonacoImpac Medical Systems, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K183037Monaco RTP SystemElekta, Inc. · 2018 · cites it directly5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 2 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 3 generations on3descendants
- K213787Monaco RTP SystemElekta Solutions AB · 2022 · 4 generations on2descendants
- K223233Monaco RTP SystemElekta Solutions AB · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −12 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −11 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −10 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −9 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −7 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −4 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −3 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −2 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| −1 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| 0 (this device) | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | — |
| +1 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +2 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +3 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
| +4 | K213787 | Monaco RTP System | Elekta Solutions AB | 2022 | — |
| +5 | K223233 | Monaco RTP System | Elekta Solutions AB | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 18 | 0 |
| 2001 | 17 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K132971 | MonacoSummary page 5…tes. Monaco is substantially equivalent to these products in intended use and safety and effectiveness. 1. Monaco RTP System IMPAC Medical Systems, Inc. K132971 2. AdvantageSim MD GE Healthcare K132944 MONACO INTENDED USE/INDICATIONS FOR USE The Monaco system is used… | 2013 |
| * | K132944 | Advantagesim MD MR Pelvic Organ at Risk SegmentationSummary page 5…in intended use and safety and effectiveness. 1. Monaco RTP System IMPAC Medical Systems, Inc. K132971 2. AdvantageSim MD GE Healthcare K132944 MONACO INTENDED USE/INDICATIONS FOR USE The Monaco system is used to make treatment plans for patients with prescriptions fo… | 2014 |
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 |
|---|---|---|---|
| K183037 | Monaco RTP System | 2018 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2023 | Class II | Z-1233-2023 | Software design | Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. |
| Jul 3, 2019 | Class II | Z-2091-2019 | Under Investigation by firm | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly. |
| Jan 10, 2017 | Class II | Z-1044-2017 | Other | Incorrect dose after editing beam number an wedge angle. |
| Dec 21, 2016 | Class II | Z-1009-2017 | Nonconforming Material/Component | Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. |
| Nov 3, 2016 | Class II | Z-0660-2017 | Software design | Incorrect Dose when using the reset function. |
| Sep 29, 2016 | Class II | Z-0076-2017 | Device Design | When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly. |
| May 18, 2016 | Class II | Z-1879-2016 | Software design | When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. |
| Oct 16, 2015 | Class II | Z-0181-2016 | Other | Unintended update of Dose and MU and Incorrect Assignment of Bolus. |
| Sep 15, 2015 | Class II | Z-0112-2016 | Device Design | Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 46 of the 184 ancestors have a recall of any class.
- Of its descendants, K183037 (Elekta, Inc., 2018) has gone furthest, with 5 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. 2015, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151233: Monaco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151233
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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