510(k) · Cleared
ClearedPrecision Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuray Incorporated · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 24, 2016 as substantially equivalent to K150873 (Accuray Incorporated, 2015) and 1 other predicate after a 63-day review. Its family tree reaches back 11 generations to 1992. 2 later devices descend from it.
- Decided
- Jun 24, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K914698 (1992). 28 ancestors in all, the oldest K882729 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations between
- 3 generations backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- 2 generations backK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- 1 generation backK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- This deviceK161136 Precision Treatment Planning SystemAccuray Incorporated · 2016
- Descendant · cites it directly · 1 of its ownK171086 Accuray Precision Treatment Planning SystemAccuray Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK212794 Accuray Precision Treatment Planning SystemAccuray Incorporated · 2021
Show all 11 generations
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 10 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 9 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 8 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 7 generations backK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- 6 generations backK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- 5 generations backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- 4 generations backK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- 3 generations backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- 2 generations backK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- 1 generation backK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- This deviceK161136 Precision Treatment Planning SystemAccuray Incorporated · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −10 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −9 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −8 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −7 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| −6 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| −5 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| −4 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
| −3 | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | 7 |
| −2 | K112776 | Tomotherapy Treatment System Fast Optimizer | Tomotherapy Incorporated | 2011 | — |
| −1 | K121934 | Tomotherapy Treatment System | Accuray Incorporated | 2012 | 8 |
| 0 (this device) | K161136 | Precision Treatment Planning System | Accuray Incorporated | 2016 | — |
| +1 | K171086 | Accuray Precision Treatment Planning System | Accuray Incorporated | 2017 | — |
| +2 | K212794 | Accuray Precision Treatment Planning System | Accuray Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemSummary page 5…tment systems. It includes the planning system features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment plannin… | 2015 |
| * | K121934 | Tomotherapy Treatment SystemSummary page 5…features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms: x Accuray’s robo… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171086 | Accuray Precision Treatment Planning System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 28 ancestors have a recall of any class.
- Of its descendants, K171086 (Accuray Incorporated, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K150873.
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. 2016, 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 Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161136: Precision Treatment 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/K161136
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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