510(k) Report

510(k) · Cleared

Cleared

Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

K041315510(k) SpecialCleared Jun 10, 200424-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

Accuray, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 10, 2004 after a 24-day review. The FDA summary names no predicate by number. 87 later devices descend from it.

Decided
Jun 10, 2004
Review
24 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2009: 6 descendants cleared2007: 2 descendants cleared2011: 4 descendants cleared2008: 1 descendant cleared2012: 3 descendants cleared2010: 3 descendants cleared2013: 5 descendants cleared2014: 4 descendants cleared2024: 3 descendants cleared2017: 7 descendants cleared2018: 7 descendants cleared2016: 3 descendants cleared2019: 5 descendants cleared2015: 3 descendants cleared2022: 4 descendants cleared2021: 7 descendants cleared2026: 5 descendants cleared2023: 9 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared200020052010201520202025
  1. This deviceK041315 Cyberknife System for Stereotactic Radiosurgery/RadiotherapyAccuray, Inc. · 2004
  2. Descendant · cites it directly · 86 of its ownK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
  3. Descendant · 2 generations on · 78 of its ownK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 77 of its ownK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
  5. Descendant · 4 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
  6. Descendant · 5 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

2006: 22007: 22008: 12009: 62010: 32011: 42012: 32013: 52014: 42015: 32016: 32017: 72018: 72019: 52020: 22021: 72022: 42023: 92024: 32025: 22026: 5
2006high 9 (2023) · low 1 (2008)2026

Most influential descendants

Showing 5 of 87 · See all
  • K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006 · cites it directly86descendants
  • K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · 2 generations on78descendants
  • K072916Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · 3 generations on77descendants
  • K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 4 generations on61descendants
  • K111106TruebeamVarian Medical Systems, Inc. · 2011 · 5 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041315Cyberknife System for Stereotactic Radiosurgery/RadiotherapyAccuray, Inc.2004—
+1K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems2006—
+2K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc.20075
+3K072916Trilogy System with RapidarcVarian Medical Systems, Inc.20072
+4K092871Trilogy MXVarian Medical Systems, Inc.20095
+5K111106TruebeamVarian Medical Systems, Inc.20115

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200720
200810
200960
201030
201140
201230
201350
201440
201530
201630
201770
201870
201950
202020
202170
202240
202390
202430
202520
202650
FIG. 1 — Lineage of K041315, 2004–2026Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (87)

See all 87

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

NumberDeviceApplicantDecidedDescendants
K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems200686

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?

  • Of its descendants, K061140 (Varian Medical Systems, 2006) has gone furthest, with 86 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—

What is it indicated for?

The CyberKnife System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Indications for use as stated in the FDA summary.

More from Accuray, Inc.

10 FDA decisions under this applicant name. See the company

  • K091999Cyberknife Robotic Radiosurgery SystemAccuray, Inc. · 20093 recalls
  • K091146Modification to Cyberknife Robotic Radiosurgery SystemAccuray, Inc. · 20093 recalls
  • K062967Cyberknife Robotic Radiosurgery SystemAccuray, Inc. · 2006
  • K051941Cybernife Stereotactic Radiosurgery SystemAccuray, Inc. · 2005
  • K032345Cyberknife System for Sterotactic Radiosurgery/RadiotherapyAccuray, Inc. · 2003

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/K041315 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041315: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041315

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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