510(k) · Cleared
Recalled · Class II · 2025PINNACLE3 Radiation Therapy Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 25, 2004 as substantially equivalent to K032724 (Adac Laboratories, 2003) after an 11-day review. Its family tree reaches back 5 generations to 1992. 39 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 25, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914698 (1992). 14 ancestors in all, the oldest K894706 (1989). 39 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 2 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 1 generation backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- This deviceK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004
- Descendant · cites it directly · 29 of its ownK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · cites it directly · 13 of its ownK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 9 of its ownK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008 · cites it directly29descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on18descendants
- K071938Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · cites it directly13descendants
- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 2 generations on12descendants
- K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −2 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −1 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| 0 (this device) | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | — |
| +1 | K080799 | Atlas-Based Autosegmentation | Computerized Medical Systems, Inc. | 2008 | — |
| +2 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +1 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
| +2 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| +3 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
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 |
|---|---|---|
| 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 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 |
|---|---|---|---|
| * | K032724 | PINNACLE3 Radiation Therapy Planning SystemSummary page 2…cation Name: Accelerator, Linear, Medical (per 21CFR section 892.5050) Predicate Devices: PinaleRadiation Therapy Planning System (K032724) Device Description: Pinnacle 3 Radiation Therapy Planning System version 7.2 (hereafter Pinnacle 3 RTP) provides radiation the… | 2003 |
What descends from it? (39)
See all 394 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 |
|---|---|---|---|---|
| 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. |
| Apr 23, 2015 | Class II | Z-1643-2015 | Software design | A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose… |
| Jul 31, 2014 | Class II | Z-2200-2015 | Software design | Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl. |
| Feb 11, 2014 | Class II | Z-1312-2014 | Software design | Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to… |
| Oct 5, 2012 | Class II | Z-0206-2013 | Process control | Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. |
| Nov 18, 2011 | Not classified | Z-0594-2012 | Software design | Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry. |
| Aug 21, 2007 | Not classified | Z-1212-2007 | Other | Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction |
The 5 latest of 7 recalls; the web page lists all.
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 12 months on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K080799 (Computerized Medical Systems, Inc., 2008) has gone furthest, with 29 descendants of its own.
- 3 other devices also cite its predicate K032724.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
Pinnacle 3 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. Pinnacle 3 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…
Read the full statement (131 words)
Pinnacle 3 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.
Pinnacle 3 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/K041577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041577: PINNACLE3 Radiation Therapy Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041577
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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