510(k) · Cleared
Recalled · 2011Monaco 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 Oct 1, 2007 as substantially equivalent to K041577 (Adac Laboratories, 2004) and 4 other predicates after an 80-day review. Its family tree reaches back 6 generations to 1992. 13 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 1, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 5
- Predicates
- 5
Its longest line of descent runs back 6 generations to K914698 (1992). 28 ancestors in all, the oldest K862643 (1987). 13 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 4 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 3 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 2 generations backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 1 generation backK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- This deviceK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 8 of its ownK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 7 of its ownK132971 MonacoImpac Medical Systems, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · cites it directly12descendants
- K110730Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · 2 generations on8descendants
- K132971MonacoImpac Medical Systems, Inc. · 2013 · 3 generations on7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 4 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −5 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −4 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −3 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −2 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| −1 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| 0 (this device) | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | — |
| +1 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| +2 | K110730 | Monaco RTP System | Computerized Medical Systems, Inc. | 2011 | 6 |
| +3 | K132971 | Monaco | Impac Medical Systems, Inc. | 2013 | 4 |
| +4 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +5 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K041577 | PINNACLE3 Radiation Therapy Planning SystemSummary page 1…ical charged-particle radiation therapy system per 2 1CFR892.5050 Substantial Equivalence: Pinnacle 3 RTP System (K04 1577); XiO RTP System (K032762); Focal Workstation (K0… | 2004 |
| * | K032762 | Xio Radiation Treatment Planning SystemSummary page 1…per 2 1CFR892.5050 Substantial Equivalence: Pinnacle 3 RTP System (K04 1577); XiO RTP System (K032762); Focal Workstation (K0 131 12); Peregrine RTP Sy… | 2003 |
| * | K013112 | Focal SimSummary page 1…Pinnacle 3 RTP System (K04 1577); XiO RTP System (K032762); Focal Workstation (K0 131 12); Peregrine RTP System (1(993675); Nulcetron Once… | 2001 |
| * | K993675 | Peregrine Radiation Therapy Dose Calculation SystemSummary page 1…XiO RTP System (K032762); Focal Workstation (K0 131 12); Peregrine RTP System (1(993675); Nulcetron Oncentra Masterplan (K(031349) Level of Concern & Rationale*: Major… | 2000 |
| * | K031349 | OTP 1.2Summary page 1…orkstation (K0 131 12); Peregrine RTP System (1(993675); Nulcetron Oncentra Masterplan (K(031349) Level of Concern & Rationale*: Major *Per FDA document "Guidance for the Content of Premarket Submissions for Softwar… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091179 | Monaco RTP System, Vmat Option | 2009 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2011 | Not classified | Z-2598-2011 | Software design | Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report. |
| Jan 13, 2011 | Not classified | Z-2561-2011 | Software design | Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00. |
| Oct 27, 2010 | Not classified | Z-2569-2011 | Software design | Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero. |
| May 31, 2010 | Not classified | Z-2564-2011 | Software design | Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans. |
| Jun 30, 2008 | Not classified | Z-2560-2011 | Software design | Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K091179 (Computerized Medical Systems, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K041577.
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. 2007, 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 create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071938: 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/K071938
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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