510(k) Report

510(k) · Cleared

Recalled · 2011

Varis 1.4G

K001643510(k) SpecialCleared Jun 23, 200024-day reviewClass II21 CFR 892.5050Recalls 8

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 Jun 23, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 183 later devices descend from it. It has been recalled 8 times.

Decided
Jun 23, 2000
Review
24 days
Class
Class II
Product code
IYE
Recalls
8
Predicates
0

183 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 3 descendants cleared2011: 4 descendants cleared2009: 3 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2014: 8 descendants cleared2012: 6 descendants cleared2015: 6 descendants cleared2016: 5 descendants cleared2021: 20 descendants cleared2018: 13 descendants cleared2017: 9 descendants cleared2013: 2 descendants cleared2019: 12 descendants cleared2026: 19 descendants cleared2020: 9 descendants cleared2022: 15 descendants cleared2025: 17 descendants cleared2023: 20 descendants cleared2024: 10 descendants cleared200020052010201520202025
  1. This deviceK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000
  2. Descendant · cites it directly · 121 of its ownK042956 VisionVarian Medical Systems, Inc. · 2005
  3. Descendant · 2 generations on · 99 of its ownK112930 Mobile MimMim Software, Inc. · 2011
  4. Descendant · cites it directly · 72 of its ownK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
  5. Descendant · 2 generations on · 69 of its ownK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
  6. Descendant · 3 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016

Showing 5 of 183 descendants. See all descendants

Descendants cleared per year

2005: 32008: 12009: 32010: 12011: 42012: 62013: 22014: 82015: 62016: 52017: 92018: 132019: 122020: 92021: 202022: 152023: 202024: 102025: 172026: 19
2005high 20 (2021) · low 0 (2006)2026

Most influential descendants

Showing 5 of 183 · See all
  • K042956VisionVarian Medical Systems, Inc. · 2005 · cites it directly121descendants
  • K112930Mobile MimMim Software, Inc. · 2011 · 2 generations on99descendants
  • K0504794D Integrated Treatment ConsoleVarian Medical Systems · 2005 · cites it directly72descendants
  • K0810364D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Varian Medical Systems, Inc. · 2008 · 2 generations on69descendants
  • K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 3 generations on68descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001643Varis 1.4GVarian Medical Systems, Inc.2000—
+1K042956VisionVarian Medical Systems, Inc.2005—
+2K112930Mobile MimMim Software, Inc.2011—
+1K0504794D Integrated Treatment ConsoleVarian Medical Systems20052
+2K0810364D Integrated Treatment Console with Patient Accessory Verification System…Varian Medical Systems, Inc.20083
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200810
200930
201010
201140
201260
201320
201480
201560
201650
201790
2018130
2019120
202090
2021200
2022150
2023200
2024100
2025170
2026190
FIG. 1 — Lineage of K001643, 2000–2026Source: 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), 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? (183)

See all 183

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

NumberDeviceApplicantDecidedDescendants
K042956VisionVarian Medical Systems, Inc.2005121
K0504794D Integrated Treatment ConsoleVarian Medical Systems200572

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 7, 2011Not classifiedZ-1957-2011Software designAn issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.
Sep 15, 2009Not classifiedZ-0133-2010Software designSoftware issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.
May 8, 2009Not classifiedZ-1809-2009Software designPotential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
Jun 2, 2008Not classifiedZ-0164-2009Software designA malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
May 21, 2008Not classifiedZ-2194-2008Software designDose delivery may be altered after import from a third party planning system during radiation therapy.
Oct 2, 2007Not classifiedZ-0720-2008Software designIncorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the…
Sep 21, 2006Not classifiedZ-0304-2007Software designSelecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
Jan 31, 2003Not classifiedZ-0633-03Software designThe product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K042956 (Varian Medical Systems, Inc., 2005) has gone furthest, with 121 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 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/K001643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001643: Varis 1.4G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001643

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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