510(k) Report

510(k) · Cleared

Cleared

Viatronix V3D Colon, Revision 1.3

K040126510(k) TraditionalCleared Apr 19, 200490-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 Apr 19, 2004 as substantially equivalent to K954355 (General Electric Co., 1995) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Apr 19, 2004
Review
90 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K954355 (1995). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1997: 1 other ancestor2013: 1 descendant cleared2012: 1 descendant clearedK954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants K954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 19950
  1. Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. This deviceK040126 Viatronix V3D Colon, Revision 1.3Viatronix, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK123566 Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc. · 2013
  4. Descendant · cites it directly · 0 of its ownK111758 Cadens (TM) ColonDog Microsystems, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc. · 2013 · cites it directly0descendants
  • K111758Cadens (TM) ColonDog Microsystems, Inc. · 2012 · cites it directly0descendants
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)K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.2004—
+1K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.2013—
+1K111758Cadens (TM) ColonDog Microsystems, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
FIG. 1 — Lineage of K040126, 1995–2013Source: 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? (5)

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
…04 2. Name of Device: Viatronix V3D) Colon, revision 1.3 3. Predicate Device Information: a. G.E. Navigator, 5 10O(k) # K954355. This system is an add-on to the Advantage Windows Workstation. Many features in the manual reference the base…
General Electric Co.1995—
*K973010Realtime 3D Diagnostic Workstation
Summary page 1
…f the following references are to the Advantage Windows Manuals. (892. 1000, Product Code LNH) b. Siemens Realtime 3D Diagnostic Workstation, 5 10(k) # K973010. The trade name of this device is 3D Virtuoso. (892.2050, Product Code: 9OLLZ)…
Siemens Medical Solutions USA, Inc.1997—
*K012072Voxar VC, Model 1.0
Summary page 2
…uct Code: 9OLLZ) 1 of 5 c. Voxar VC Model 1.0, 5 10(k) # K012072. The trade name of this device is Voxar Colonscreen. (892.2050, Product Code: 9OLLZ) d. Vital Images Vitrea 2,…
Voxar Limited2001—
*K002519Vitrea 2, Version 2.1
Summary page 2
…5 10(k) # K012072. The trade name of this device is Voxar Colonscreen. (892.2050, Product Code: 9OLLZ) d. Vital Images Vitrea 2, Version 2.1, 5 10(k) # K002519. (892.2050, Product Code: 90LLZ) e. Viatronix Visualization System, 5 10(k) # K002780. This system name is…
Vital Images, Inc.20001
*K002780Viatronix Visualization System (VVS)
Summary page 2
…: 9OLLZ) d. Vital Images Vitrea 2, Version 2.1, 5 10(k) # K002519. (892.2050, Product Code: 90LLZ) e. Viatronix Visualization System, 5 10(k) # K002780. This system name is sometimes abbreviated as VVS. (892.2050, Product Code: 9OLLZ) 4. Device Description:…
Viatronix, Inc.2000—

Also cleared against K954355: 9 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.20130
K111758Cadens (TM) ColonDog Microsystems, Inc.20120

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 5 ancestors has a recall of any class.
  • Of its descendants, K123566 (Fujifilm Medical Systems U.S.A, Inc., 2013) has gone furthest, with 0 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 Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine…

Read the full statement (128 words)

The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive print and distribute colon 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
  • K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc. · 2003
  • 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
  • K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc. · 2003
  • K032483Viatronix V3D Explorer, Revision 1.2Viatronix, 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/K040126 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040126: Viatronix V3D Colon, Revision 1.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040126

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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