510(k) Report

510(k) · Cleared

Recalled · 2011

Trilogy MX

K092871510(k) TraditionalCleared Nov 30, 200973-day reviewClass II21 CFR 892.5050Recalls 5

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 Nov 30, 2009 as substantially equivalent to K072916 (Varian Medical Systems, Inc., 2007) and 6 other predicates after a 73-day review. Its family tree reaches back 5 generations to 1995. 61 later devices descend from it. It has been recalled 5 times.

Decided
Nov 30, 2009
Review
73 days
Class
Class II
Product code
IYE
Recalls
5
Predicates
7

Its longest line of descent runs back 5 generations to K926449 (1995). 25 ancestors in all, the oldest K864886 (1987). 61 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2006: 2 other ancestors2004: 3 other ancestors2001: 1 other ancestor2005: 1 other ancestor1999: 1 other ancestor2003: 2 other ancestors2000: 2 other ancestors1987: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1991: 1 other ancestor2012: 2 descendants cleared2011: 2 descendants cleared2017: 7 descendants cleared2018: 5 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2019: 5 descendants cleared2016: 2 descendants cleared2015: 3 descendants cleared2022: 4 descendants cleared2021: 7 descendants cleared2026: 5 descendants cleared2023: 9 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared2024: 2 descendants clearedK926449 · Varian Multileaf Collimator, Release 4.0 · Varian Assoc., Inc. · 1995K973889 · Varian Multileaf Collimator with Dynamic Arc Therapy Feature · Varian Medical Systems, Inc. · 1997K990085 · Millennium MLC -120 · Varian Assoc., Inc. · 1999 · recalledK050442 · Millennium Multi-Leaf Collimator · Varian Medical Systems · 2005 · recalledK071992 · High-Definition 120 Multileaf Collimator (HD120 MLC) · Varian Medical Systems · 2007 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 10 descendants5 generations forward: 8 descendants6 generations forward: 7 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants9 generations forward: 4 descendants10 generations forward: 4 descendants11 generations forward: 3 descendants12 generations forward: 1 descendant K071992 · High-Definition 120 Multileaf Collimator (HD120 MLC) · Varian Medical Systems · 2007 · recalledK050442 · Millennium Multi-Leaf Collimator · Varian Medical Systems · 2005 · recalledK990085 · Millennium MLC -120 · Varian Assoc., Inc. · 1999 · recalledK973889 · Varian Multileaf Collimator with Dynamic Arc Therapy Feature · Varian Medical Systems, Inc. · 1997K926449 · Varian Multileaf Collimator, Release 4.0 · Varian Assoc., Inc. · 1995−50+5+10
  1. Root · 5 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
  2. 4 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
  3. 3 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
  4. 2 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
  5. 1 generation backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
  6. This deviceK092871 Trilogy MXVarian Medical Systems, Inc. · 2009
  7. Descendant · cites it directly · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
  8. Descendant · 2 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
  9. Descendant · 2 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
  10. Descendant · 3 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
  11. Descendant · 4 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2011: 22012: 22013: 22014: 22015: 32016: 22017: 72018: 52019: 52020: 22021: 72022: 42023: 92024: 22025: 22026: 5
2011high 9 (2023) · low 2 (2011)2026

Most influential descendants

Showing 5 of 61 · See all
  • K111106TruebeamVarian Medical Systems, Inc. · 2011 · cites it directly43descendants
  • K123291TruebeamVarian Medical Systems, Inc. · 2012 · 2 generations on37descendants
  • K123808AgilityElekta, Ltd. · 2013 · 2 generations on36descendants
  • K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 3 generations on31descendants
  • K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 4 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K926449Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc.1995—
−4K973889Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc.1997—
−3K990085Millennium MLC -120Varian Assoc., Inc.19992
−2K050442Millennium Multi-Leaf CollimatorVarian Medical Systems20052
−1K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems20074
0 (this device)K092871Trilogy MXVarian Medical Systems, Inc.2009—
+1K111106TruebeamVarian Medical Systems, Inc.20115
+2K123291TruebeamVarian Medical Systems, Inc.2012—
+2K123808AgilityElekta, Ltd.20132
+3K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.20142
+4K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199620
199710
199910
200020
200110
200320
200430
200510
200620
200720
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201220
201320
201420
201530
201620
201770
201850
201950
202020
202170
202240
202390
202420
202520
202650
FIG. 1 — Lineage of K092871, 1995–2026Source: 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? (7)

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
*K072916Trilogy System with Rapidarc
Summary page 1
…Trilogy Mx Radiotherapy Delivery System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: Th…
Varian Medical Systems, Inc.20072
*K042720ON-Board Imager Device
Summary page 1
…Trilogy Mx Radiotherapy Delivery System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy…
Varian Medical Systems20045
*K063270RPM Respiratory Gating System
Summary page 1
…y Mx Radiotherapy Delivery System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy MxTM Rad…
Varian Medical Systems, Inc.20061
*K0810364D Integrated Treatment Console with Patient Accessory Verification System (Pavs)
Summary page 1
…otherapy Delivery System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy MxTM Radiotherapy…
Varian Medical Systems, Inc.20083
*K003636Portalvision
Summary page 1
…Delivery System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy MxTM Radiotherapy Delivery…
Varian Medical Systems, Inc.2001—
*K071992High-Definition 120 Multileaf Collimator (HD120 MLC)
Summary page 1
…System Predicate Devices: Trilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy MxTM Radiotherapy Delivery System i…
Varian Medical Systems20074
*K050442Millennium Multi-Leaf Collimator
Summary page 1
…rilogy Radiotherapy System and Accessories: K072916, K042720, K063270, K081036, K003636, K071992, K050442 Device Description: The Trilogy MxTM Radiotherapy Delivery System is a medical linear…
Varian Medical Systems20052

Also cleared against K072916: 5 other devices →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K111106TruebeamVarian Medical Systems, Inc.201143
K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated201115
K111862Viewray SystemViewray, Incorporated20129

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 21, 2011Not classifiedZ-3101-2011Nonconforming Material/ComponentVarian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.
May 19, 2011Not classifiedZ-2766-2011Device DesignImaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
Apr 5, 2011Not classifiedZ-2181-2011Nonconforming Material/ComponentPosition sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities…
May 24, 2010Not classifiedZ-0106-2011Software designDue to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that…
Dec 1, 2009Not classifiedZ-1001-2011Device DesignA circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 18 of the 25 ancestors have a recall of any class.
  • Of its descendants, K111106 (Varian Medical Systems, Inc., 2011) has gone furthest, with 43 descendants of its own.
  • 5 other devices also cite its predicate K072916.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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?

Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Indications for use as stated in the FDA summary.

Also cleared against K072916

5 other devices cite the same predicate.

  • K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 20125 recalls
  • K101751Varian Unique Single Energy Linear AcceleratorVarian Medical Systems, Oncology Systems · 20101 recall
  • K100890Varian High Energy Linear AcceleratorVarian Medical Systems · 201011 recalls
  • K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc. · 20091 recall
  • K081188Trilogy with External System Gating InterfaceVarian Medical Systems, Inc. · 20081 recall

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/K092871 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092871: Trilogy MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092871

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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