510(k) · Cleared
ClearedQuickPlan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siris Medical · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 11, 2015 as substantially equivalent to K141283 (Varian Medical Systems, Inc., 2014) after a 93-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Sep 11, 2015
- Review
- 93 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010975 (2001). 15 ancestors in all, the oldest K992762 (2000). No later device cites it as a predicate yet.
- Root · 11 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 2 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 1 generation backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- This deviceK151560 QuickPlanSiris Medical · 2015
Show all 11 generations
- Root · 11 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 10 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 9 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 8 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 7 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 4 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 3 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 2 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 1 generation backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- This deviceK151560 QuickPlanSiris Medical · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −10 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −9 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −8 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −7 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −6 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −5 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −4 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −3 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −2 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −1 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| 0 (this device) | K151560 | QuickPlan | Siris Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K141283 | Eclipse Treatment Planning SystemSummary page 4…apy Treatment, Product Code MUJ Legally Marketed Predicate Eclipse Treatment Planning System manufactured by Varian Device: Medical Systems Inc., K141283, Class II per 21 CFR 892.5050, Medical charged-particle radiation therapy system, Produ… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K141283.
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. 2015, 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 QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan. The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable…
Read the full statement (107 words)
The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.
The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan Software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.
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/K151560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151560: QuickPlan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151560
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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