510(k) · Cleared
Recalled · Class II · 2016Monaco RTP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 24, 2011 as substantially equivalent to K091179 (Computerized Medical Systems, Inc., 2009) and 2 other predicates after a 100-day review. Its family tree reaches back 8 generations to 1992. 8 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 24, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 8 generations to K914698 (1992). 46 ancestors in all, the oldest K862643 (1987). 8 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 6 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 5 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 4 generations backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 3 generations backK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- 2 generations backK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- This deviceK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK132971 MonacoImpac Medical Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132971MonacoImpac Medical Systems, Inc. · 2013 · cites it directly7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 2 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 3 generations on5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 4 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −7 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −6 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −5 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −4 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| −3 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| −2 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
| −1 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| 0 (this device) | K110730 | Monaco RTP System | Computerized Medical Systems, Inc. | 2011 | — |
| +1 | K132971 | Monaco | Impac Medical Systems, Inc. | 2013 | 4 |
| +2 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +3 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +4 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +5 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 18.7 · 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 |
|---|---|---|---|
| * | K091179 | Monaco RTP System, Vmat OptionSummary page 2…s cleared for distribution and are currently being actively marketed in the United States. I1. Monaco RTP System Computerized Medical Systems, Inc. K091 179 2. ERGO++RTP System Computerized Medical Systems, Inc. K080601 3. Eclipse Treatment Planning System Var… | 2009 |
| * | K080601 | Ergo++ Version 1.7Summary page 2…ed States. I1. Monaco RTP System Computerized Medical Systems, Inc. K091 179 2. ERGO++RTP System Computerized Medical Systems, Inc. K080601 3. Eclipse Treatment Planning System Varian Medical Systems K102011I MONACO INTENDED USE The Monaco system is u… | 2008 |
| * | K102011 | Eclipse Treatment Planning SystemSummary page 2…K091 179 2. ERGO++RTP System Computerized Medical Systems, Inc. K080601 3. Eclipse Treatment Planning System Varian Medical Systems K102011I MONACO INTENDED USE The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiat… | 2010 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132971 | Monaco | 2013 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2016 | Class II | Z-2712-2016 | Unknown/Undetermined by firm | In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be… |
| Jul 2, 2013 | Class II | Z-2276-2013 | Device Design | Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. |
| May 22, 2013 | Class II | Z-2277-2013 | Labeling design | Patient needs to be positioned as indicated by the treatment plan. |
| Feb 11, 2013 | Class II | Z-0841-2013 | Nonconforming Material/Component | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. |
| Jun 21, 2012 | Class II | Z-2007-2012 | Software design | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. |
| Mar 5, 2012 | Not classified | Z-1365-2012 | Software design | An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose. |
The 5 latest of 6 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 19 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 14 of the 46 ancestors have a recall of any class.
- Of its descendants, K132971 (Impac Medical Systems, Inc., 2013) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K091179.
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. 2011, 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 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/K110730 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110730: Monaco RTP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110730
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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