510(k) · Cleared
Recalled · Class II · 2016Monaco
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 Nov 20, 2013 as substantially equivalent to K110730 (Computerized Medical Systems, Inc., 2011) and 3 other predicates after a 58-day review. Its family tree reaches back 9 generations to 1992. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 20, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 9 generations to K914698 (1992). 51 ancestors in all, the oldest K862643 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations between
- 3 generations backK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · Recalled
- This deviceK132971 MonacoImpac Medical Systems, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
- Descendant · 5 generations on · 2 of its ownK213787 Monaco RTP SystemElekta Solutions AB · 2022
Show all 9 generations
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 8 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 7 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 6 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 5 generations backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 4 generations backK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- 3 generations backK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · Recalled
- This deviceK132971 MonacoImpac Medical Systems, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151233MonacoImpac Medical Systems, Inc. · 2015 · cites it directly6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 2 generations on5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 3 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 4 generations on3descendants
- K213787Monaco RTP SystemElekta Solutions AB · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −8 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −7 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −6 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −5 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| −4 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| −3 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
| −2 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| −1 | K110730 | Monaco RTP System | Computerized Medical Systems, Inc. | 2011 | 6 |
| 0 (this device) | K132971 | Monaco | Impac Medical Systems, Inc. | 2013 | — |
| +1 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +2 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +3 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +4 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
| +5 | K213787 | Monaco RTP System | Elekta Solutions AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 18.6 · 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? (4)
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 |
|---|---|---|---|
| * | K110730 | Monaco RTP SystemSummary page 3…ived clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091 179) and again when Dynamic Conformal Arc planning was added (KI 110730). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data fr-om a linear accelerator. The system th… | 2011 |
| * | K080601 | Ergo++ Version 1.7Summary page 2…ed use and safety and effectiveness. I. Monaco RTP System IMPAC Medical Systems, Inc. KI 10730 2. ERGO-+- IMPAC Medical Systems, Inc. K080601I 3. Eclipse Treatment Planning System Varian Medical Systems, Inc. K102011I 4. Oncentra Nulcetron Corpo… | 2008 |
| * | K102011 | Eclipse Treatment Planning SystemSummary page 2…s, Inc. KI 10730 2. ERGO-+- IMPAC Medical Systems, Inc. K080601I 3. Eclipse Treatment Planning System Varian Medical Systems, Inc. K102011I 4. Oncentra Nulcetron Corporation K 12 1448 MONACO INTENDED USE/INDICATIONS FOR USE The Monaco system is us… | 2010 |
| * | K121448 | Oncentra, Oncentra External Beam, Oncentra BrachySummary page 2…Systems, Inc. K080601I 3. Eclipse Treatment Planning System Varian Medical Systems, Inc. K102011I 4. Oncentra Nulcetron Corporation K 12 1448 MONACO INTENDED USE/INDICATIONS FOR USE The Monaco system is used to make treatment plans for patients with prescriptions fo… | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151233 | Monaco | 2015 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2016 | Class II | Z-1009-2017 | Nonconforming Material/Component | Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. |
| Nov 17, 2016 | Class II | Z-0668-2017 | Software design | Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. |
| Dec 19, 2014 | Class II | Z-1237-2015 | Other | Incorrect CT to ED when using the Monaco Image Statistics Tool. |
| Aug 18, 2014 | Class II | Z-2581-2014 | Software design | Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 17 of the 51 ancestors have a recall of any class.
- Of its descendants, K151233 (Impac Medical Systems, Inc., 2015) has gone furthest, with 6 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. 2013, 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/K132971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132971: Monaco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132971
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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