510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Eclipse Treatment Planning System

K172163510(k) SpecialCleared Aug 15, 201728-day reviewClass II21 CFR 892.5050Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Aug 15, 2017 as substantially equivalent to K170969 (Varian Medical Systems, Inc., 2017) after a 28-day review. Its family tree reaches back 13 generations to 2001. 29 later devices descend from it. It has been recalled once.

Decided
Aug 15, 2017
Review
28 days
Class
Class II
Product code
MUJ
Recalls
1
Predicates
1

Its longest line of descent runs back 13 generations to K010975 (2001). 17 ancestors in all, the oldest K992762 (2000). 29 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 3 other ancestors2023: 7 descendants cleared2018: 2 descendants cleared2020: 3 descendants cleared2022: 2 descendants cleared2021: 3 descendants cleared2025: 5 descendants cleared2024: 3 descendants cleared2026: 4 descendants clearedK010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalledK030981 · Eclipse · Varian Medical Systems, Inc. · 2003K041403 · Eclipse with Aaa · Varian Medical Systems · 2004K050296 · Eclipse Treatment Planning System · Varian Medical Systems · 2005K071873 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK073020 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK091492 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2009 · recalledK102011 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2010 · recalledK131891 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2013K133247 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014K141283 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014 · recalledK152393 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2015 · recalledK170969 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2017 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 10 generations back: 3 other ancestors11 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K170969 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2017 · recalledK152393 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2015 · recalledK141283 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014 · recalledK133247 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014K131891 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2013K102011 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2010 · recalledK091492 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2009 · recalledK073020 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK071873 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK050296 · Eclipse Treatment Planning System · Varian Medical Systems · 2005K041403 · Eclipse with Aaa · Varian Medical Systems · 2004K030981 · Eclipse · Varian Medical Systems, Inc. · 2003K010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalled−10−50+5
  1. Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. 9 generations between
  3. 3 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
  4. 2 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
  5. 1 generation backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  6. This deviceK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017
  7. Descendant · cites it directly · 26 of its ownK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
  8. Descendant · 2 generations on · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
  9. Descendant · 2 generations on · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
  10. Descendant · 2 generations on · 5 of its ownK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
  11. Descendant · 3 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
Show all 13 generations
  1. Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. 12 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
  3. 11 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
  4. 10 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
  5. 9 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  6. 8 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  7. 7 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
  8. 6 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
  9. 5 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
  10. 4 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
  11. 3 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
  12. 2 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
  13. 1 generation backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  14. This deviceK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2018: 22020: 32021: 32022: 22023: 72024: 32025: 52026: 4
2018high 7 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 29 · See all
  • K181145Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · cites it directly26descendants
  • K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · 2 generations on9descendants
  • K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · 2 generations on5descendants
  • K200608Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020 · 2 generations on5descendants
  • K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K010975Eclipse 6.5Varian Medical Systems, Inc.20013
−12K030981EclipseVarian Medical Systems, Inc.2003—
−11K041403Eclipse with AaaVarian Medical Systems2004—
−10K050296Eclipse Treatment Planning SystemVarian Medical Systems2005—
−9K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20075
−8K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20076
−7K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20092
−6K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20105
−5K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2013—
−4K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2014—
−3K141283Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20141
−2K152393Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20151
−1K170969Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20171
0 (this device)K172163Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2017—
+1K181145Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20181
+2K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy…Varian Medical Systems, Inc.2020—
+2K210645RayStation 10.1RaySearch Laboratories AB (PUBL)20216
+2K200608Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc.2020—
+3K211867RayStation 11.0RaySearch Laboratories AB (PUBL)20218

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
202030
202130
202220
202370
202430
202550
202640
FIG. 1 — Lineage of K172163, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K170969Eclipse Treatment Planning System
Summary page 4
…50, MUJ, Class II Common/Usual Name: Eclipse TPS, Eclipse, Treatment Planning System Predicate Devices: Eclipse Treatment Planning System 15.1.1 (K170969). Device Description: The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provid…
Varian Medical Systems, Inc.20171

What descends from it? (29)

See all 29

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181145Eclipse Treatment Planning SystemVarian Medical Systems, Inc.201826
K223724Mozi TPSManteia Technologies Co., Ltd.20230
K173940Astroid Planning App.Decimal, LLC20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 26, 2018Class IIZ-0771-2019Software designThere is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 9 of the 17 ancestors have a recall of any class.
  • Of its descendants, K181145 (Varian Medical Systems, Inc., 2018) has gone furthest, with 26 descendants of its own.

How does its category compare?

All MUJ devices

MUJ 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

2007: 42008: 92009: 162010: 112011: 92012: 82013: 52014: 92015: 132016: 52017: 72018: 72019: 92020: 92021: 112022: 82023: 102024: 92025: 102026 (partial year): 9
2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007: 67 days median2008: 63 days median2009: 84 days median2010: 56 days median2011: 103 days median2012: 59 days median2013: 64 days median2014: 108 days median2015: 78 days median2016: 80 days median2017: 30 days median2018: 53 days median2019: 56 days median2020: 104 days median2021: 87 days median2022: 168 days median2023: 140 days median2024: 122 days median2025: 186 days median2026 (partial year): 233 days median
2007high 233 (2026) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUJ

2in 2023

2007: 42008: 102009: 112010: 232011: 172012: 42013: 62014: 22015: 72016: 132017: 42018: 32019: 42020: 22021: 42022: 32023: 22026 (partial year): 2
2007high 23 (2010) · low 0 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUJ

21in 2025

2007: 242008: 512009: 242010: 782011: 732012: 392013: 332014: 352015: 302016: 272017: 162018: 252019: 252020: 262021: 152022: 222023: 762024: 92025: 21
2007high 78 (2010) · low 9 (2024)2025

MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007467424
20089631051
200916841124
201011562378
201191031773
2012859439
2013564633
20149108235
20151378730
20165801327
2017730416
2018753325
2019956425
20209104226
20211187415
20228168322
202310140276
2024912209
202510186021
202692332—

What is it indicated for?

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Indications for use as stated in the FDA summary.

More from Varian Medical Systems, Inc.

172 FDA decisions under this applicant name. See the company

  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K260750Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
  • K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026
  • K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
  • K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc. · 2026

Recent decisions in MUJ

The MUJ category page

  • K261655RT Elements (4.6)Brainlab SE · 2026
  • K260750Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
  • K253050RadOncAIInformai · 2026
  • K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V. · 2026
  • K252784eXaSkin PlusAnatomical Geometry S.L. · 2026

https://510kreport.com/device/K172163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172163: Eclipse 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/K172163

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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