510(k) · Cleared
ClearedViatronix V3D-Cardiac, Revision 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viatronix, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 5, 2008 as substantially equivalent to K041267 (General Electric Medical Systems, 2004) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 5, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000315 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 2 generations backK013422 Cardiq FunctionGE Medical Systems · 2001
- 1 generation backK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- This deviceK083293 Viatronix V3D-Cardiac, Revision 1.0Viatronix, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −2 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| −1 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| 0 (this device) | K083293 | Viatronix V3D-Cardiac, Revision 1.0 | Viatronix, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041267 | Cardiq Analysis IiiSummary page 1…stem 3. Predicate Device Information: Predicate Device: GE. Medical System, CardIQ Xpress, revision 6.12.3, 5 10(k) #K041267 and #K013422 4. Device Description: The Viatronix V3D-Cardiac is a software device for evaluating scanned images o… | 2004 |
| * | K013422 | Cardiq FunctionSummary page 1…Predicate Device Information: Predicate Device: GE. Medical System, CardIQ Xpress, revision 6.12.3, 5 10(k) #K041267 and #K013422 4. Device Description: The Viatronix V3D-Cardiac is a software device for evaluating scanned images of heart. It i… | 2001 |
| † | K033361 | Viatronix V3D Vascular, Revision 1.0 | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- 6 other devices also cite its predicate K041267.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Viatronix V3D-Cardiac is intended to be used for the display and 2D/3D visualization of medical image data derived from CT of the human heart. The goal of this non-invasive, image analysis software package is to assist physician in diagnosing of cardiovascular disease to include, coronary artery disease, functional problem of left ventricle, myocardium anomaly, other heart diseases, and follow-up for stent/graft placement, bypasses and plaque…
Read the full statement (238 words)
The Viatronix V3D-Cardiac is intended to be used for the display and 2D/3D visualization of medical image data derived from CT of the human heart. The goal of this non-invasive, image analysis software package is to assist physician in diagnosing of cardiovascular disease to include, coronary artery disease, functional problem of left ventricle, myocardium anomaly, other heart diseases, and follow-up for stent/graft placement, bypasses and plaque imaging. The image post-processing tools are applied real time on-line by the physician's interactive demand. There is no image processing stage required prior to the start of the using of the V3D-Cardiac. The Viatronix V3D-Cardiac provides a set of fully or semi-automated tools, including, rib cage removal, initial coronary vessel tree segmentation, selected vessel segmentation, vessel cross-sectional size measurements, and left ventricle volume functional parameter computation. The V3D-Cardiac will also provide automated setting and display of conventional cardiac imaging planes based on a single user input: selection of the center of the aorta valve. The automatic 2D/3D view correlation is available for vessel analysis views. User can virtually fly thru the vessel lumen in the endoluminal 3D view. Manual tools for adjusting location of center of mitral valve for left ventricle region segmentation are provided. The V3D-Cardiac is intended for use by radiologist, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant coronary artery, left ventricle and other heart anatomy images, utilizing PC hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083293: Viatronix V3D-Cardiac, Revision 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083293
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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