510(k) Report

510(k) · Cleared

Cleared

Eclipse Treatment Planning System

K050296510(k) TraditionalCleared Nov 3, 2005269-day reviewClass II21 CFR 892.5050

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

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

Cleared on Nov 3, 2005 as substantially equivalent to K041403 (Varian Medical Systems, 2004) and 3 other predicates after a 269-day review. Its family tree reaches back 3 generations to 2001. 101 later devices descend from it.

Decided
Nov 3, 2005
Review
269 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K010975 (2001). 7 ancestors in all, the oldest K992762 (2000). 101 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 3 other ancestors2007: 3 descendants cleared2009: 4 descendants cleared2011: 3 descendants cleared2010: 4 descendants cleared2014: 7 descendants cleared2013: 3 descendants cleared2015: 4 descendants cleared2020: 6 descendants cleared2017: 10 descendants cleared2018: 7 descendants cleared2016: 3 descendants cleared2021: 8 descendants cleared2022: 7 descendants cleared2019: 6 descendants cleared2024: 5 descendants cleared2023: 10 descendants cleared2026: 6 descendants cleared2025: 5 descendants clearedK010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalledK030981 · Eclipse · Varian Medical Systems, Inc. · 2003K041403 · Eclipse with Aaa · Varian Medical Systems · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 9 descendants5 generations forward: 13 descendants6 generations forward: 12 descendants7 generations forward: 9 descendants8 generations forward: 11 descendants9 generations forward: 5 descendants10 generations forward: 5 descendants11 generations forward: 6 descendants12 generations forward: 5 descendants13 generations forward: 6 descendants14 generations forward: 6 descendants15 generations forward: 3 descendants16 generations forward: 1 descendant K041403 · Eclipse with Aaa · Varian Medical Systems · 2004K030981 · Eclipse · Varian Medical Systems, Inc. · 2003K010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalled0+5+10+15
  1. Root · 3 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. 2 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
  3. 1 generation backK041403 Eclipse with AaaVarian Medical Systems · 2004
  4. This deviceK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
  5. Descendant · cites it directly · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  7. Descendant · 3 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
  8. Descendant · 4 generations on · 58 of its ownK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
  9. Descendant · 5 generations on · 37 of its ownK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2007: 32009: 42010: 42011: 32013: 32014: 72015: 42016: 32017: 102018: 72019: 62020: 62021: 82022: 72023: 102024: 52025: 52026: 6
2007high 10 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 101 · See all
  • K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · cites it directly94descendants
  • K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 2 generations on92descendants
  • K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 3 generations on87descendants
  • K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · 4 generations on58descendants
  • K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013 · 5 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010975Eclipse 6.5Varian Medical Systems, Inc.20013
−2K030981EclipseVarian Medical Systems, Inc.2003—
−1K041403Eclipse with AaaVarian Medical Systems2004—
0 (this device)K050296Eclipse Treatment Planning SystemVarian Medical Systems2005—
+1K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20075
+2K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20076
+3K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20092
+4K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20105
+5K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200940
201040
201130
201330
201470
201540
201630
2017100
201870
201960
202060
202180
202270
2023100
202450
202550
202660
FIG. 1 — Lineage of K050296, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*K041403Eclipse with Aaa
Summary page 1
…n therapy treatment, 21 CFR 892.5050 Class II Common/Usual Name: Eclipse Predicate Device(s): 1. Varian Eclipse, K041403 2. Varian Helios, K021268 3. Varian ProtonVision, K002312…
Varian Medical Systems2004—
*K021268Eclipse, Helios Option
Summary page 1
…21 CFR 892.5050 Class II Common/Usual Name: Eclipse Predicate Device(s): 1. Varian Eclipse, K041403 2. Varian Helios, K021268 3. Varian ProtonVision, K002312 4. Varian BrachyVision, K992762 Product Des…
Varian Medical Systems, Inc.2002—
*K002312Proton Vision 7.0
Summary page 1
…al Name: Eclipse Predicate Device(s): 1. Varian Eclipse, K041403 2. Varian Helios, K021268 3. Varian ProtonVision, K002312 4. Varian BrachyVision, K992762 Product Description: The Varian Eclipse Treatment Planning System (E…
Varian Medical Systems, Inc.2000—
*K992762Brachyvision 6.0
Summary page 1
…pse, K041403 2. Varian Helios, K021268 3. Varian ProtonVision, K002312 4. Varian BrachyVision, K992762 Product Description: The Varian Eclipse Treatment Planning System (Eclipse TPS) provides software tools for planning the tr…
Varian Assoc., Inc.20001

What descends from it? (101)

See all 101

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

NumberDeviceApplicantDecidedDescendants
K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.200794
K071760Modification to: Eclipse Treatment Planning SystemVarian Medical Systems, Inc.200735

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 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K071873 (Varian Medical Systems, Inc., 2007) has gone furthest, with 94 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.

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.

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34 FDA decisions under this applicant name. See the company

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The MUJ category page

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https://510kreport.com/device/K050296 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050296: 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/K050296

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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