510(k) Report

510(k) · Cleared

Cleared

Varis Images, Including Ximatron Digital Imaging Option

K952313510(k) TraditionalCleared Aug 16, 199591-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Assoc., Inc. · LLZ System, Image Processing, Radiological

Cleared on Aug 16, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 123 later devices descend from it.

Decided
Aug 16, 1995
Review
91 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2005: 2 descendants cleared2011: 1 descendant cleared2009: 1 descendant cleared2014: 4 descendants cleared2012: 4 descendants cleared2015: 2 descendants cleared2016: 3 descendants cleared2021: 13 descendants cleared2018: 8 descendants cleared2017: 2 descendants cleared2019: 7 descendants cleared2026: 17 descendants cleared2020: 8 descendants cleared2022: 11 descendants cleared2025: 15 descendants cleared2023: 14 descendants cleared2024: 10 descendants cleared1995200020052010201520202025
  1. This deviceK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
  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 · 3 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
  5. Descendant · 4 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
  6. Descendant · 5 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

1998: 12005: 22009: 12011: 12012: 42014: 42015: 22016: 32017: 22018: 82019: 72020: 82021: 132022: 112023: 142024: 102025: 152026: 17
1998high 17 (2026) · low 0 (1999)2026

Most influential descendants

Showing 5 of 123 · See all
  • K042956VisionVarian Medical Systems, Inc. · 2005 · cites it directly121descendants
  • K112930Mobile MimMim Software, Inc. · 2011 · 2 generations on99descendants
  • K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 3 generations on68descendants
  • K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 4 generations on67descendants
  • K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 5 generations on54descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952313Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc.1995—
+1K042956VisionVarian Medical Systems, Inc.2005—
+2K112930Mobile MimMim Software, Inc.2011—
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.2016—
+4K172218MIM – Y90 DosimetryMim Software, Inc.2017—
+5K180815MIM - SPECTRA QuantMim Software, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200520
200910
201110
201240
201440
201520
201630
201720
201880
201970
202080
2021130
2022110
2023140
2024100
2025150
2026170
FIG. 1 — Lineage of K952313, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (123)

See all 123

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

NumberDeviceApplicantDecidedDescendants
K042956VisionVarian Medical Systems, Inc.2005121
K982857Helax-Imcon, Version 1.0Helax AB19980

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, K042956 (Varian Medical Systems, Inc., 2005) has gone furthest, with 121 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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 LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K952313 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952313: Varis Images, Including Ximatron Digital Imaging Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952313

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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