510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Varian C/D-Series Clinacs (Clinac 600 C/D)

K926321510(k) TraditionalCleared Aug 9, 1994601-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 Assoc., Inc. · IYE Accelerator, Linear, Medical

Cleared on Aug 9, 1994 after a 601-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled 3 times.

Decided
Aug 9, 1994
Review
601 days
Class
Class II
Product code
IYE
Recalls
3
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2016: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2017: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK926321 Varian C/D-Series Clinacs (Clinac 600 C/D)Varian Assoc., Inc. · 1994
  2. Descendant · cites it directly · 13 of its ownK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
  4. Descendant · 3 generations on · 10 of its ownK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
  5. Descendant · 4 generations on · 3 of its ownK161146 Radixact Treatment Delivery SystemAccuray Incorporated · 2016 · Recalled
  6. Descendant · 4 generations on · 2 of its ownK161136 Precision Treatment Planning SystemAccuray Incorporated · 2016

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22012: 12015: 12016: 22017: 22018: 12020: 22021: 12023: 1
2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · cites it directly13descendants
  • K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011 · 2 generations on11descendants
  • K121934Tomotherapy Treatment SystemAccuray Incorporated · 2012 · 3 generations on10descendants
  • K161146Radixact Treatment Delivery SystemAccuray Incorporated · 2016 · 4 generations on3descendants
  • K161136Precision Treatment Planning SystemAccuray Incorporated · 2016 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926321Varian C/D-Series Clinacs (Clinac 600 C/D)Varian Assoc., Inc.1994—
+1K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated20087
+2K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated2011—
+3K121934Tomotherapy Treatment SystemAccuray Incorporated20128
+4K161146Radixact Treatment Delivery SystemAccuray Incorporated20161
+4K161136Precision Treatment Planning SystemAccuray Incorporated2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201210
201510
201620
201720
201810
202020
202110
202310
FIG. 1 — Lineage of K926321, 1994–2023Source: 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? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated200813

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 14, 2012Class IIZ-2383-2012Nonconforming Material/ComponentSome X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The…
Nov 28, 2011Not classifiedZ-0692-2012Device DesignAn event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
Feb 4, 2005Not classifiedZ-0777-05Software designTreatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082005 (Tomotherapy Incorporated, 2008) has gone furthest, with 13 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 Assoc., Inc.

86 FDA decisions under this applicant name. See the company

  • K000922Proton VisionVarian Assoc., Inc. · 2000
  • K992762Brachyvision 6.0Varian Assoc., Inc. · 20001 recall
  • K992751SomavisionVarian Assoc., Inc. · 2000
  • K992753Cadplan Plus: 3D Treatment Planning SystemVarian Assoc., Inc. · 1999
  • K990085Millennium MLC -120Varian Assoc., Inc. · 19992 recalls

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/K926321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926321: Varian C/D-Series Clinacs (Clinac 600 C/D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926321

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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