510(k) Report

510(k) · Cleared

Recalled · 2008

Eclipse 6.5

K010975510(k) SpecialCleared May 2, 200130-day reviewClass II21 CFR 892.5050Recalls 3

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. · IYE Accelerator, Linear, Medical

Cleared on May 2, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 108 later devices descend from it. It has been recalled 3 times.

Decided
May 2, 2001
Review
30 days
Class
Class II
Product code
IYE
Recalls
3
Predicates
0

108 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 2 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2007: 3 descendants cleared2009: 4 descendants cleared2011: 3 descendants cleared2014: 8 descendants cleared2010: 4 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 cleared200020052010201520202025
  1. This deviceK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001
  2. Descendant · cites it directly · 107 of its ownK030981 EclipseVarian Medical Systems, Inc. · 2003
  3. Descendant · 2 generations on · 102 of its ownK041403 Eclipse with AaaVarian Medical Systems · 2004
  4. Descendant · 3 generations on · 101 of its ownK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
  5. Descendant · 4 generations on · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 5 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12007: 32009: 42010: 42011: 32012: 22013: 32014: 82015: 42016: 32017: 102018: 72019: 62020: 62021: 82022: 72023: 102024: 52025: 52026: 6
2003high 10 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 108 · See all
  • K030981EclipseVarian Medical Systems, Inc. · 2003 · cites it directly107descendants
  • K041403Eclipse with AaaVarian Medical Systems · 2004 · 2 generations on102descendants
  • K050296Eclipse Treatment Planning SystemVarian Medical Systems · 2005 · 3 generations on101descendants
  • K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 4 generations on94descendants
  • K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 5 generations on92descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010975Eclipse 6.5Varian Medical Systems, Inc.2001—
+1K030981EclipseVarian Medical Systems, Inc.2003—
+2K041403Eclipse with AaaVarian Medical Systems2004—
+3K050296Eclipse Treatment Planning SystemVarian Medical Systems2005—
+4K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20075
+5K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20076

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200730
200940
201040
201130
201220
201330
201480
201540
201630
2017100
201870
201960
202060
202180
202270
2023100
202450
202550
202660
FIG. 1 — Lineage of K010975, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (108)

See all 108

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030981EclipseVarian Medical Systems, Inc.2003107

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2008Not classifiedZ-0861-2009Software designPossible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and…
Jun 11, 2008Not classifiedZ-2308-2008Software designSoftware anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.
Nov 23, 2005Not classifiedZ-0393-06OtherThe export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030981 (Varian Medical Systems, Inc., 2003) has gone furthest, with 107 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

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 IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K010975 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010975: Eclipse 6.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010975

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026