510(k) · Cleared
ClearedVesselIQ Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 16, 2021 as substantially equivalent to K060779 (GE Healthcare, 2006) after a 343-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Feb 16, 2021
- Review
- 343 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871859 (1987). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 3 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 2 generations backK031871 AutoboneGe Medical Systems Europe · 2003
- 1 generation backK060779 Advance Vessel Analysis IIGE Healthcare · 2006
- This deviceK200626 VesselIQ XpressGE Medical Systems SCS · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −3 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −2 | K031871 | Autobone | Ge Medical Systems Europe | 2003 | — |
| −1 | K060779 | Advance Vessel Analysis II | GE Healthcare | 2006 | — |
| 0 (this device) | K200626 | VesselIQ Xpress | GE Medical Systems SCS | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K060779 | Advance Vessel Analysis IISummary page 4…Classification Panel: Radiology Regulatory Class: Class II Predicate Device 1: Advanced Vessel Analysis II 510(k) number K060779, cleared on April 5, 2006 Regulation Number: 21CFR 892.1750, Computed Tomography X-Ray System Prod… | 2006 |
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 34 years and passes through 5 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060779.
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. 2021, 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?
VesselIQ Xpress is an optional, non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology, aiding physicians in diagnosis and determination of treatment paths, from a set of Computed Tomography (CT) Angiographic images. VesselIQ Xpress is an option for the Advantage Workstation (AW) platform, CT Scanner, and/or PACS, which can be used in the analysis of 2D and 3D CT Angiography…
Read the full statement (226 words)
VesselIQ Xpress is an optional, non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology, aiding physicians in diagnosis and determination of treatment paths, from a set of Computed Tomography (CT) Angiographic images.
VesselIQ Xpress is an option for the Advantage Workstation (AW) platform, CT Scanner, and/or PACS, which can be used in the analysis of 2D and 3D CT Angiography images/data for the purpose of cardiovascular and vascular disease assessment. This software-only device is designed to support physician assessment for a wide variety of clinical uses such as stenosis analysis, pre/post stent planning, pre/post valve replacement planning, and directional vessel tortuosity visualization.
VesselIQ Xpress’ automatic visualization tools provide users the capability to segment bony structures for accurate identification of the vessels. Additional tools enable analysis of the vascular anatomy including the aorta, valves, and branching vessels for: anatomical sizing; density and volume analysis of segmented vasculature and calcified / non-calcified plaque; and measurements of abnormalities.
The TAVI Analysis option for VesselIQ Xpress is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to aid in evaluation of appropriate access pathways for interventional procedure planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200626: VesselIQ Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200626
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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