510(k) · Cleared
ClearedViatronix V3D Colon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viatronix, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 7, 2002 as substantially equivalent to K954355 (General Electric Co., 1995) and 4 other predicates after a 6-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Mar 7, 2002
- Review
- 6 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. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- This deviceK020658 Viatronix V3D ColonViatronix, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK023943 CT ColonographyGe Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK041270 CT Colonography IIGeneral Electric Medical Systems · 2004
- Descendant · 2 generations on · 0 of its ownK090220 Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009
- Descendant · 3 generations on · 0 of its ownK061372 Centricity AW Suite OptionGe Healthcare Information Technologies · 2006 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K023943CT ColonographyGe Medical Systems, Inc. · 2003 · cites it directly3descendants
- K041270CT Colonography IIGeneral Electric Medical Systems · 2004 · 2 generations on2descendants
- K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009 · 2 generations on0descendants
- K061372Centricity AW Suite OptionGe Healthcare Information Technologies · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| 0 (this device) | K020658 | Viatronix V3D Colon | Viatronix, Inc. | 2002 | — |
| +1 | K023943 | CT Colonography | Ge Medical Systems, Inc. | 2003 | — |
| +2 | K041270 | CT Colonography II | General Electric Medical Systems | 2004 | — |
| +2 | K090220 | Colon View, Model CSCV-001A | Toshibamedical Systems Corporation | 2009 | — |
| +3 | K061372 | Centricity AW Suite Option | Ge Healthcare Information Technologies | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954355 | Advantage Windows 3D with Navigator OptionSummary page 1…ctor of QA/RA Date Summary Prepared: January 7, 2002 Name of the Device: Viatronix V3D Colon, revision 1.1 Predicate Device Information: . 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 manua… | 1995 |
| * | K973010 | Realtime 3D Diagnostic WorkstationSummary page 1…. Therefore, some of the following references are to the Advantage Windows Manuals. (892.1000, Product Code: LNH) . Siemens Realtime 3D Diagnostic Workstation, 510(k) # K973010. The trade name of this device is 3D Virtuoso. (892.2050, Product Code: 90LLZ) 1of5 . Voxar VC Model 1.0, 510(k… | 1997 |
| * | K012072 | Voxar VC, Model 1.0Summary page 2…nostic Workstation, 510(k) # K973010. The trade name of this device is 3D Virtuoso. (892.2050, Product Code: 90LLZ) 1of5 . Voxar VC Model 1.0, 510(k) # K012072. The trade name of this device is Voxar Colonscreen. (892.2050, Product Code: 90LLZ) . Vital Images Vitrea 2, Version 2.1, 510(k… | 2001 |
| * | K002519 | Vitrea 2, Version 2.1Summary page 2…Voxar VC Model 1.0, 510(k) # K012072. The trade name of this device is Voxar Colonscreen. (892.2050, Product Code: 90LLZ) . Vital Images Vitrea 2, Version 2.1, 510(k) # K002519. (892.2050, Product Code: 90LLZ) Viatronix Visualization System, 510(k) # K002780. This system name is sometimes abbreviated as… | 2000 |
| * | K002780 | Viatronix Visualization System (VVS)Summary page 2…creen. (892.2050, Product Code: 90LLZ) . Vital Images Vitrea 2, Version 2.1, 510(k) # K002519. (892.2050, Product Code: 90LLZ) Viatronix Visualization System, 510(k) # K002780. This system name is sometimes abbreviated as VVS. (892.2050, Product Code: 90LLZ) Device D ion: The Viatronix V3D Colon contai… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023943 | CT Colonography | 2003 | 3 |
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?
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
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 screening a colon to detect polyps, masses, cancers 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…
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 screening a colon to detect polyps, masses, cancers 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 screening a colon. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020658: Viatronix V3D Colon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020658
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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