510(k) · Cleared
Recalled · Class II · 2016PINNACLE3 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. · IYE Accelerator, Linear, Medical
Cleared on Jun 14, 2013 as substantially equivalent to K102216 (Computerized Medical Systems, Inc., 2010) after a 65-day review. Its family tree reaches back 8 generations to 2001. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 2013
- Review
- 65 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010975 (2001). 28 ancestors in all, the oldest K862643 (1987). 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 7 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 6 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 5 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 4 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 3 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- This deviceK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013
- Descendant · cites it directly · 4 of its ownK151435 MRCATPhilips Medical Systems MR Finland · 2016
- Descendant · 2 generations on · 3 of its ownK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
- Descendant · 3 generations on · 2 of its ownK193109 MRCAT brainPhilips Medical Systems MR Finland · 2020
- Descendant · 4 generations on · 0 of its ownK211841 MRI PlannerSpectronic Medical AB · 2022
- Descendant · 4 generations on · 0 of its ownK214081 MRCAT Head & NeckPhilips OY · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151435MRCATPhilips Medical Systems MR Finland · 2016 · cites it directly4descendants
- K182888MRCAT PelvisPhilips Medical Systems MR Finland · 2019 · 2 generations on3descendants
- K193109MRCAT brainPhilips Medical Systems MR Finland · 2020 · 3 generations on2descendants
- K211841MRI PlannerSpectronic Medical AB · 2022 · 4 generations on0descendants
- K214081MRCAT Head & NeckPhilips OY · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −7 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −6 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −5 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −4 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −3 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −2 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −1 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| 0 (this device) | K130992 | PINNACLE3 Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2013 | — |
| +1 | K151435 | MRCAT | Philips Medical Systems MR Finland | 2016 | — |
| +2 | K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019 | — |
| +3 | K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020 | — |
| +4 | K211841 | MRI Planner | Spectronic Medical AB | 2022 | — |
| +4 | K214081 | MRCAT Head & Neck | Philips OY | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K102216 | Xio RTP SystemSummary page 1…ccelerator, Linear, Medical Classification Regulation: 892.5050 Product Code: MUJ Device Class: Class Il Classification Panel: Radiology, RASO 5. Predicate Devices K102216, Computerized Medical Systems, Inc., Xio RTP System — Proton Spot Scanning 6. Device Description Pinnacle®® Radiation Therapy Pl… | 2010 |
What descends from it? (6)
2 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 |
|---|---|---|---|---|
| Jan 8, 2016 | Class II | Z-0745-2016 | Device Design | In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 28 ancestors have a recall of any class.
- Of its descendants, K151435 (Philips Medical Systems MR Finland, 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K102216.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
Pinnacle’” Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle®’ Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle® Proton, which supports proton therapy planning. The full Pinnacle®” Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing…
Read the full statement (140 words)
Pinnacle’” Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle®’ Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle® Proton, which supports proton therapy planning. The full Pinnacle®” Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.
Pinnacle?®” 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130992: PINNACLE3 Radiation Therapy Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130992
Report an extraction error
Are you the manufacturer?
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