510(k) · Cleared
ClearedViatronic V3D Calcium Scoring
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 7, 2001 as substantially equivalent to K003484 (Scimage, Inc., 2001) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Dec 7, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945512 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 2 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 1 generation backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- This deviceK013146 Viatronic V3D Calcium ScoringViatronix, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK032823 Medicheart, Model Release 1Medicsight · 2003
Most influential descendants
Showing 1 of 1 · See all- K032823Medicheart, Model Release 1Medicsight · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −2 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −1 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| 0 (this device) | K013146 | Viatronic V3D Calcium Scoring | Viatronix, Inc. | 2001 | — |
| +1 | K032823 | Medicheart, Model Release 1 | Medicsight | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003484 | Netra Workstation and Netramd SoftwareSummary page 1…pared: September 17, 2001 Name of the Device: Viatronix V3D Calcium Scoring System Predicate Device Information: 1. Netra Workstation and NetraMD Software System, K#003484, SCImage, Los Altos, CA (892.2050, Product Code: 90LLZ) 2. CT Coronary Artery Calcification Scoring Option for Advantage Windows… | 2001 |
| * | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage WindowsSummary page 1…nd NetraMD Software System, K#003484, SCImage, Los Altos, CA (892.2050, Product Code: 90LLZ) 2. CT Coronary Artery Calcification Scoring Option for Advantage Windows, K#982004, GE Medical Systems, Milwaukee, WI (892.1750, Product Code: 90JAK) 3. VScore Image Processing Software with EKG Signal Gating O… | 1998 |
| * | K001682 | Vscore with Ekg Signal GatingSummary page 1…s, K#982004, GE Medical Systems, Milwaukee, WI (892.1750, Product Code: 90JAK) 3. VScore Image Processing Software with EKG Signal Gating Option for Cardiac Scoring, K#001682, Vital Images, Plymouth, MN (892.1750, Product Code: 90JAK) Device Description: The V-3D Calcium Scoring System for Coronary A… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032823 | Medicheart, Model Release 1 | 2003 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032823 (Medicsight, 2003) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003484.
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.
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 Calcium Scoring System is intended to be used by a trained
physician for the review and analysis of CT images as an aid in cardiac analysis.
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/K013146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013146: Viatronic V3D Calcium Scoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013146
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026