510(k) · Cleared
ClearedSmart Vessel Analysis (Smart VA) Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 24, 1999 as substantially equivalent to K954355 (General Electric Co., 1995) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1993. 60 later devices descend from it.
- Decided
- Nov 24, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926258 (1993). 2 ancestors in all. 60 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK926258 DLXGE Medical Systems · 1993
- This deviceK993792 Smart Vessel Analysis (Smart VA) OptionGe Medical Systems, Inc. · 1999
- Descendant · cites it directly · 55 of its ownK060779 Advance Vessel Analysis IIGE Healthcare · 2006
- Descendant · 2 generations on · 51 of its ownK061370 Cardiq FusionGE Healthcare · 2006
- Descendant · cites it directly · 22 of its ownK033361 Viatronix V3D Vascular, Revision 1.0Viatronix, Inc. · 2003
- Descendant · 2 generations on · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 3 generations on · 20 of its ownK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K060779Advance Vessel Analysis IIGE Healthcare · 2006 · cites it directly55descendants
- K061370Cardiq FusionGE Healthcare · 2006 · 2 generations on51descendants
- K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc. · 2003 · cites it directly22descendants
- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · 2 generations on21descendants
- K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926258 | DLX | GE Medical Systems | 1993 | — |
| 0 (this device) | K993792 | Smart Vessel Analysis (Smart VA) Option | Ge Medical Systems, Inc. | 1999 | — |
| +1 | K060779 | Advance Vessel Analysis II | GE Healthcare | 2006 | — |
| +2 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| +1 | K033361 | Viatronix V3D Vascular, Revision 1.0 | Viatronix, Inc. | 2003 | — |
| +2 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +3 | K103465 | Synapse 3D Cardiac Tools | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K954355 | Advantage Windows 3D with Navigator OptionSummary page 1…or : General Electric Medical Systems, Milwaukee, W1 Marketed Devices: The Smart VA is substantially equivalent to the devices listed below: Model: Advantage Windows 3D (K954355) with Navigator Option and DLX (K926258) Manufacturer: General Electric Medical Systems, Buc Cedex, FRANCE Device Description: S… | 1995 |
| * | K926258 | DLXSummary page 1…ilwaukee, W1 Marketed Devices: The Smart VA is substantially equivalent to the devices listed below: Model: Advantage Windows 3D (K954355) with Navigator Option and DLX (K926258) Manufacturer: General Electric Medical Systems, Buc Cedex, FRANCE Device Description: SmartVA is a software post-processing pac… | 1993 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 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?
Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
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/K993792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993792: Smart Vessel Analysis (Smart VA) Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993792
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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