510(k) Report

510(k) · Cleared

Recalled · 2011

Trilogy Radiotherapy Delivery System

K033343510(k) TraditionalCleared Dec 23, 200367-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 Dec 23, 2003 as substantially equivalent to K913119 (Varian Assoc., Inc., 1991) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1991. 87 later devices descend from it. It has been recalled 3 times.

Decided
Dec 23, 2003
Review
67 days
Class
Class II
Product code
IYE
Recalls
3
Predicates
2

Its longest line of descent runs back 1 generation to K913119 (1991). 2 ancestors in all. 87 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2007: 2 descendants cleared2006: 2 descendants cleared2009: 6 descendants cleared2008: 1 descendant cleared2012: 3 descendants cleared2010: 3 descendants cleared2011: 4 descendants cleared2013: 5 descendants cleared2024: 3 descendants cleared2014: 4 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 clearedK913119 · Varian C-Series Clinacs (Clinac 2300C/D) · Varian Assoc., Inc. · 1991 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 11 descendants5 generations forward: 7 descendants6 generations forward: 7 descendants7 generations forward: 10 descendants8 generations forward: 8 descendants9 generations forward: 7 descendants10 generations forward: 6 descendants11 generations forward: 5 descendants12 generations forward: 4 descendants13 generations forward: 4 descendants14 generations forward: 3 descendants15 generations forward: 1 descendant K913119 · Varian C-Series Clinacs (Clinac 2300C/D) · Varian Assoc., Inc. · 1991 · recalled0+5+10+15
  1. Root · 1 generation backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
  2. This deviceK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003
  3. Descendant · cites it directly · 86 of its ownK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
  4. Descendant · cites it directly · 78 of its ownK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 77 of its ownK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
  7. Descendant · 4 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 · cites it directly78descendants
  • K072916Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · 2 generations on77descendants
  • K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 3 generations on61descendants
  • K111106TruebeamVarian Medical Systems, Inc. · 2011 · 4 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913119Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc.19916
0 (this device)K033343Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc.2003—
+1K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems2006—
+1K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc.20075
+2K072916Trilogy System with RapidarcVarian Medical Systems, Inc.20072
+3K092871Trilogy MXVarian Medical Systems, Inc.20095
+4K111106TruebeamVarian Medical Systems, Inc.20115

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

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 K033343, 1991–2026Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K913119Varian C-Series Clinacs (Clinac 2300C/D)
Summary page 1
…Product Code: 90 IYE 3. Predicate Devices to claim substantial equivalence: a. Varian Medical Systems' Clinac 2300 C/D, K913119 b. Brainlab Novalis Shaped Beam Surgery System, K002509 4. Description of the Device: The modified 2300C/D, which…
Varian Assoc., Inc.19916
*K002509Novalis (Shaped Beam Surgery System)
Summary page 1
…edicate Devices to claim substantial equivalence: a. Varian Medical Systems' Clinac 2300 C/D, K913119 b. Brainlab Novalis Shaped Beam Surgery System, K002509 4. Description of the Device: The modified 2300C/D, which will now be called the TrilogyTM Radiotherapy Delivery Syst…
Brainlab AG20001

Also cleared against K913119: 1 other device →

What descends from it? (87)

See all 87

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

NumberDeviceApplicantDecidedDescendants
K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems200686
K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc.200778

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 9, 2011Not classifiedZ-0181-2012Device DesignVarian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
May 26, 2011Not classifiedZ-2978-2011Device DesignOn Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.
May 13, 2011Not classifiedZ-2778-2011Nonconforming Material/ComponentSome drive stand bolts may fail to meet mechanical specifications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K061140 (Varian Medical Systems, 2006) has gone furthest, with 86 descendants of its own.
  • 1 other device also cites its predicate K913119.

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 Trilogy TM Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

Indications for use as stated in the FDA summary.

Also cleared against K913119

1 other device cites the same predicate.

  • K023636Blocking TraySoutheastern Radiation Products, Inc. · 2002

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/K033343 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033343: Trilogy Radiotherapy Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033343

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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