510(k) · Cleared
Recalled · Class II · 2025Pinnacle Radiation Therapy Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Feb 9, 2017 as substantially equivalent to K130992 (Philips Medical Systems (Cleveland), Inc., 2013) after a 30-day review. Its family tree reaches back 9 generations to 2001. It has been recalled 3 times.
- Decided
- Feb 9, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010975 (2001). 29 ancestors in all, the oldest K862643 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 1 generation backK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013 · Recalled
- This deviceK170086 Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2017
Show all 9 generations
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 7 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 6 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 5 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 1 generation backK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013 · Recalled
- This deviceK170086 Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −8 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −7 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −6 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −5 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −4 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −3 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −2 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −1 | K130992 | PINNACLE3 Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2013 | 1 |
| 0 (this device) | K170086 | Pinnacle Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K130992 | PINNACLE3 Radiation Therapy Planning SystemSummary page 4…Philips Medical Systems (Cleveland), Inc. 510(k) Clearance: K130992 Classification Name: Accelerator, Linear, Medical Classificat… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-2570-2025 | Software design | Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations. |
| Jul 17, 2025 | Class II | Z-2239-2025 | Software change control | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , |
| Aug 30, 2022 | Class II | Z-1744-2022 | Device Design | When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K130992.
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. 2017, 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?
Pinnacle3® Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3® Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle³ Proton, which supports proton therapy planning. The full Pinnacle3® Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing…
Read the full statement (140 words)
Pinnacle3® Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3® Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle³ Proton, which supports proton therapy planning. The full Pinnacle3® Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.
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. Plans generated using this system is 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/K170086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170086: Pinnacle 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/K170086
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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