510(k) Report

510(k) · Cleared

Cleared

Viatronix V3D Explorer, Revision 1.2

K032483510(k) TraditionalCleared Aug 22, 200310-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 Aug 22, 2003 as substantially equivalent to K954355 (General Electric Co., 1995) and 2 other predicates after a 10-day review. Its family tree reaches back 1 generation to 1995. 76 later devices descend from it.

Decided
Aug 22, 2003
Review
10 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K954355 (1995). 3 ancestors in all. 76 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2004: 1 descendant cleared2010: 2 descendants cleared2008: 1 descendant cleared2006: 2 descendants cleared2012: 1 descendant cleared2018: 5 descendants cleared2016: 2 descendants cleared2011: 1 descendant cleared2017: 4 descendants cleared2022: 9 descendants cleared2013: 2 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 clearedK954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 13 descendants6 generations forward: 12 descendants7 generations forward: 7 descendants8 generations forward: 7 descendants9 generations forward: 8 descendants10 generations forward: 5 descendants11 generations forward: 2 descendants12 generations forward: 2 descendants13 generations forward: 1 descendant K954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 19950+5+10
  1. Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. This deviceK032483 Viatronix V3D Explorer, Revision 1.2Viatronix, Inc. · 2003
  3. Descendant · cites it directly · 75 of its ownK033955 RTISTMirada Solutions, Ltd. · 2004
  4. Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
  5. Descendant · 3 generations on · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
  6. Descendant · 4 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
  7. Descendant · 5 generations on · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22008: 12010: 22011: 12012: 12013: 22014: 12015: 12016: 22017: 42018: 52019: 52020: 32021: 82022: 92023: 82024: 62025: 52026: 9
2004high 9 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 76 · See all
  • K033955RTISTMirada Solutions, Ltd. · 2004 · cites it directly75descendants
  • K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
  • K102687Mirada RTMirada Medical, Ltd. · 2010 · 3 generations on37descendants
  • K130393Mirada RTXMirada Medical, Ltd. · 2013 · 4 generations on36descendants
  • K181572Workflow BoxMirada Medical, Ltd. · 2018 · 5 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954355Advantage Windows 3D with Navigator OptionGeneral Electric Co.1995—
0 (this device)K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.2003—
+1K033955RTISTMirada Solutions, Ltd.2004—
+2K101228Mirada XDMirada Medical, Ltd.2010—
+3K102687Mirada RTMirada Medical, Ltd.2010—
+4K130393Mirada RTXMirada Medical, Ltd.2013—
+5K181572Workflow BoxMirada Medical, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200810
201020
201110
201210
201320
201410
201510
201620
201740
201850
201950
202030
202180
202290
202380
202460
202550
202690
FIG. 1 — Lineage of K032483, 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 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? (3)

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
*K954355Advantage Windows 3D with Navigator Option
Summary page 1
…essing software system c) Classification name: 9OLLZ- Image Processing system 3. Predicate Device Information: Predicate Device #1: G.E. Navigator, 510(k) # K954355. This system is an add-on to the Advantage Windows Workstation. Many features in the manual reference the base workstation manual…
General Electric Co.1995—
*K002519Vitrea 2, Version 2.1Vital Images, Inc.20001
*K002780Viatronix Visualization System (VVS)
Summary page 1
…e base workstation manuals. Predicate Device #2: Vital Images Vitrea 2, Version 2.1, 5 10(k) # KO025 19. Predicate Device #3: Viatronix Visualization System, 5 10(k) # K002780. This system name is sometimes abbreviated as VVS.…
Viatronix, Inc.2000—

Also cleared against K954355: 9 other devices →

What descends from it? (76)

See all 76

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033955RTISTMirada Solutions, Ltd.200475

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K033955 (Mirada Solutions, Ltd., 2004) has gone furthest, with 75 descendants of its own.
  • 9 other devices also cite its predicate K954355.

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—

What is it indicated for?

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular locationl displacement, study/analysis and evaluation of both hard and soft tissues as well…

Read the full statement (151 words)

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular locationl displacement, study/analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.

Indications for use as stated in the FDA summary.

Also cleared against K954355

9 other devices cite the same predicate.

  • K061532Gentle Colon (Revision 2.0)Rendoscopy, Inc. · 2006
  • K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc. · 2004
  • K022789Viatronix V3D ExplorerViatronix, Inc. · 2002
  • K020658Viatronix V3D ColonViatronix, Inc. · 2002
  • K012313CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 20011 recall
  • K993792Smart Vessel Analysis (Smart VA) OptionGe Medical Systems, Inc. · 1999

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
  • K022789Viatronix V3D ExplorerViatronix, Inc. · 2002
  • K020658Viatronix V3D ColonViatronix, Inc. · 2002

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/K032483 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032483: Viatronix V3D Explorer, Revision 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032483

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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