510(k) Report

510(k) · Cleared

Cleared

Eclipse

K030981510(k) TraditionalCleared Jun 24, 200388-day reviewClass II21 CFR 892.1000

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. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 24, 2003 as substantially equivalent to K010975 (Varian Medical Systems, Inc., 2001) after an 88-day review. Its family tree reaches back 1 generation to 2001. 107 later devices descend from it.

Decided
Jun 24, 2003
Review
88 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010975 (2001). 107 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 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 clearedK010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 9 descendants7 generations forward: 13 descendants8 generations forward: 12 descendants9 generations forward: 9 descendants10 generations forward: 11 descendants11 generations forward: 5 descendants12 generations forward: 5 descendants13 generations forward: 6 descendants14 generations forward: 5 descendants15 generations forward: 6 descendants16 generations forward: 6 descendants17 generations forward: 3 descendants18 generations forward: 1 descendant K010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalled0+5+10+15
  1. Root · 1 generation backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. This deviceK030981 EclipseVarian Medical Systems, Inc. · 2003
  3. Descendant · cites it directly · 102 of its ownK041403 Eclipse with AaaVarian Medical Systems · 2004
  4. Descendant · 2 generations on · 101 of its ownK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
  5. Descendant · 3 generations on · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 4 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  7. Descendant · 5 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12007: 32009: 42010: 42011: 32012: 22013: 32014: 82015: 42016: 32017: 102018: 72019: 62020: 62021: 82022: 72023: 102024: 52025: 52026: 6
2004high 10 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 107 · See all
  • K041403Eclipse with AaaVarian Medical Systems · 2004 · cites it directly102descendants
  • K050296Eclipse Treatment Planning SystemVarian Medical Systems · 2005 · 2 generations on101descendants
  • K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 3 generations on94descendants
  • K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 4 generations on92descendants
  • K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 5 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K030981, 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 LNH? 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 LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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
*K010975Eclipse 6.5Varian Medical Systems, Inc.20013

What descends from it? (107)

See all 107

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

NumberDeviceApplicantDecidedDescendants
K041403Eclipse with AaaVarian Medical Systems2004102
K041937RestituResonant Medical, Inc.20043

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?

  • Its one ancestor has a recall.
  • Of its descendants, K041403 (Varian Medical Systems, 2004) has gone furthest, with 102 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar radiotherapy devices with x- ray energies from 1 -50MV, as well as Cobalt-60 and electron energies from 1 - 50MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers and beam intensity modulators. Eclipse…

Read the full statement (106 words)

The Varian Eclipse device is used to plan photon and electron radiation therapy

treatments employing linear accelerators and other similar radiotherapy devices with x-

ray energies from 1 -50MV, as well as Cobalt-60 and electron energies from 1 - 50MeV.

Eclipse will plan the 3D radiotherapy treatment approaches to combined modality

plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers and

beam intensity modulators.

Eclipse includes also tools for treatment preparation (diagnostic image analysis,

contouring and segmentation) and plan review.

As part of the VARIS Vision System, Eclipse integrates the treatment planning in overall

therapy process, while taking advantage of the Varian Vision database.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 LNH

The LNH category page

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https://510kreport.com/device/K030981 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030981: Eclipse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030981

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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