510(k) · Cleared
Recalled · 2004PINNACLE3 Radiation Therapy Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 9, 2003 as substantially equivalent to K993923 (Adac Laboratories, 2000) and 1 other predicate after a 36-day review. Its family tree reaches back 4 generations to 1992. 44 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914698 (1992). 13 ancestors in all, the oldest K894706 (1989). 44 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 1 generation backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- This deviceK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003
- Descendant · cites it directly · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- Descendant · 2 generations on · 29 of its ownK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · cites it directly39descendants
- K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008 · 2 generations on29descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 3 generations on18descendants
- K071938Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · 2 generations on13descendants
- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −1 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| 0 (this device) | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | — |
| +1 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| +2 | K080799 | Atlas-Based Autosegmentation | Computerized Medical Systems, Inc. | 2008 | — |
| +3 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +2 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
| +3 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K993923 | Adac PINNACLE3TM Radiation Therapy Planning SystemSummary page 1…ame: Accelerator, Linear, Medical (per 2 lCFR section 892.5050) Predicate Devices: Pinnacle3 Radiation Therapy Planning Software (K993923) P’ IMRT (K002237) Device Description: Pinnacle3 Radiation Therapy Planning Software ver… | 2000 |
| * | K002237 | P3IMRT TMSummary page 1…lCFR section 892.5050) Predicate Devices: Pinnacle3 Radiation Therapy Planning Software (K993923) P’ IMRT (K002237) Device Description: Pinnacle3 Radiation Therapy Planning Software version 6.6 (hereafter Pinnacle3 RTP) provides radiation ther… | 2001 |
What descends from it? (44)
See all 444 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2004 | Not classified | Z-0911-04 | Other | A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K041577 (Adac Laboratories, 2004) has gone furthest, with 39 descendants of its own.
- 4 other devices also cite its predicate K993923.
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.
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?
Pinnacle3 Radiation Therapy Planning System version 6.6 provides support for conformal arc treatment planning. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment…
Read the full statement (143 words)
Pinnacle3 Radiation Therapy Planning System version 6.6 provides support for conformal arc treatment planning.
Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes.
The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.
Plans generated using this system are used in the determination of the course of a patient’s radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032724: PINNACLE3 Radiation Therapy Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032724
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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