510(k) · Cleared
ClearedAdvance Vessel Analysis II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 5, 2006 as substantially equivalent to K993792 (Ge Medical Systems, Inc., 1999) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1987. 55 later devices descend from it.
- Decided
- Apr 5, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K871859 (1987). 13 ancestors in all. 55 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 2 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK031871 AutoboneGe Medical Systems Europe · 2003
- This deviceK060779 Advance Vessel Analysis IIGE Healthcare · 2006
- Descendant · cites it directly · 51 of its ownK061370 Cardiq FusionGE Healthcare · 2006
- Descendant · 2 generations on · 20 of its ownK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · 3 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
- Descendant · cites it directly · 16 of its ownK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K061370Cardiq FusionGE Healthcare · 2006 · cites it directly51descendants
- K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011 · 2 generations on20descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 3 generations on19descendants
- K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · cites it directly19descendants
- K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −2 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −1 | K031871 | Autobone | Ge Medical Systems Europe | 2003 | — |
| 0 (this device) | K060779 | Advance Vessel Analysis II | GE Healthcare | 2006 | — |
| +1 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| +2 | K103465 | Synapse 3D Cardiac Tools | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +3 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
| +1 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K993792 | Smart Vessel Analysis (Smart VA) OptionSummary page 1…es The Advanced Vessel Analysis II is substantially equivalent to the devices listed below: *Model: Smart Vessel Analysis Option, 5 10(k) # K993792 *Model: CardIQ Analysis III, 5 10(k) # K04 1267 *Model: Auto Bone, 510(k) # K03 187… | 1999 |
| * | K041267 | Cardiq Analysis IiiSummary page 1…o the devices listed below: *Model: Smart Vessel Analysis Option, 5 10(k) # K993792 *Model: CardIQ Analysis III, 5 10(k) # K04 1267 *Model: Auto Bone, 510(k) # K03 1871 *Manufacturer: General Electric Medical Systems, Buc… | 2004 |
| * | K031871 | AutoboneSummary page 1…Smart Vessel Analysis Option, 5 10(k) # K993792 *Model: CardIQ Analysis III, 5 10(k) # K04 1267 *Model: Auto Bone, 510(k) # K03 1871 *Manufacturer: General Electric Medical Systems, Buc, France Device Description: CT Advanced vessel an… | 2003 |
What descends from it? (55)
See all 555 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K061370 (GE Healthcare, 2006) has gone furthest, with 51 descendants of its own.
- 2 other devices also cite its predicate K993792.
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?
Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data…
Read the full statement (163 words)
Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
AVA II automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure area's of abnormalities within a vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060779: Advance Vessel Analysis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060779
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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