510(k) Report

510(k) · Cleared

Cleared

Viatronix Visualization System (VVS)

K002780510(k) TraditionalCleared Nov 17, 200072-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

Viatronix, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 17, 2000 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 86 later devices descend from it.

Decided
Nov 17, 2000
Review
72 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

86 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2003: 2 descendants cleared2002: 2 descendants cleared2013: 3 descendants cleared2012: 2 descendants cleared2009: 1 descendant cleared2010: 2 descendants cleared2008: 1 descendant cleared2006: 3 descendants cleared2018: 5 descendants cleared2016: 2 descendants cleared2011: 1 descendant cleared2017: 4 descendants cleared2022: 9 descendants cleared2021: 8 descendants cleared2019: 5 descendants cleared2020: 3 descendants cleared2023: 8 descendants cleared2026: 9 descendants cleared2014: 1 descendant cleared2025: 5 descendants cleared2015: 1 descendant cleared2024: 6 descendants cleared200020052010201520202025
  1. This deviceK002780 Viatronix Visualization System (VVS)Viatronix, Inc. · 2000
  2. Descendant · cites it directly · 76 of its ownK032483 Viatronix V3D Explorer, Revision 1.2Viatronix, Inc. · 2003
  3. Descendant · 2 generations on · 75 of its ownK033955 RTISTMirada Solutions, Ltd. · 2004
  4. Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
  5. Descendant · 4 generations on · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
  6. Descendant · 5 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 32006: 32008: 12009: 12010: 22011: 12012: 22013: 32014: 12015: 12016: 22017: 42018: 52019: 52020: 32021: 82022: 92023: 82024: 62025: 52026: 9
2002high 9 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 86 · See all
  • K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc. · 2003 · cites it directly76descendants
  • K033955RTISTMirada Solutions, Ltd. · 2004 · 2 generations on75descendants
  • K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
  • K102687Mirada RTMirada Medical, Ltd. · 2010 · 4 generations on37descendants
  • K130393Mirada RTXMirada Medical, Ltd. · 2013 · 5 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002780Viatronix Visualization System (VVS)Viatronix, Inc.2000—
+1K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.2003—
+2K033955RTISTMirada Solutions, Ltd.2004—
+3K101228Mirada XDMirada Medical, Ltd.2010—
+4K102687Mirada RTMirada Medical, Ltd.2010—
+5K130393Mirada RTXMirada Medical, Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200430
200630
200810
200910
201020
201110
201220
201330
201410
201510
201620
201740
201850
201950
202030
202180
202290
202380
202460
202550
202690
FIG. 1 — Lineage of K002780, 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 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
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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? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.200376
K020658Viatronix V3D ColonViatronix, Inc.20024
K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042
K022789Viatronix V3D ExplorerViatronix, Inc.20020

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, K032483 (Viatronix, Inc., 2003) has gone furthest, with 76 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 Viatronix, Inc.

8 FDA decisions under this applicant name. See the company

  • K083293Viatronix V3D-Cardiac, Revision 1.0Viatronix, Inc. · 2008
  • K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc. · 2004
  • K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc. · 2003
  • K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc. · 2003
  • K022789Viatronix V3D ExplorerViatronix, Inc. · 2002

Recent decisions in LLZ

The LLZ category page

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  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
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https://510kreport.com/device/K002780 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002780: Viatronix Visualization System (VVS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002780

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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