510(k) · Cleared
ClearedCardiq Fusion
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 May 30, 2006 as substantially equivalent to K041267 (General Electric Medical Systems, 2004) and 4 other predicates after a 13-day review. Its family tree reaches back 5 generations to 1996. 51 later devices descend from it.
- Decided
- May 30, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K954874 (1996). 20 ancestors in all, the oldest K871859 (1987). 51 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 4 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 3 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 2 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 1 generation backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- This deviceK061370 Cardiq FusionGE Healthcare · 2006
- Descendant · cites it directly · 20 of its ownK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · 2 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 · 2 generations on · 16 of its ownK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011 · cites it directly20descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 2 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 · 2 generations on16descendants
- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −4 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −3 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −2 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −1 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| 0 (this device) | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| +1 | K103465 | Synapse 3D Cardiac Tools | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +2 | 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 | — |
| +2 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| +3 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 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? (5)
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…ox 414, Milwaukee, WI 53210 Marketed Devices CardIQ Fusion is substantially equivalent to the devices listed below: * Model: CardIQ Pro, 510(k) #K041267 · Manufacturer: GE Medical Systems SCS, Buc, France * Model: CT/PET Fusion, 510(k) # K010336 * M… | 2004 |
| * | K010336 | Advantage Windows CT/Pet FusionSummary page 1…* Model: CardIQ Pro, 510(k) #K041267 · Manufacturer: GE Medical Systems SCS, Buc, France * Model: CT/PET Fusion, 510(k) # K010336 * Manufacturer: GE Medical Systems SCSB France * Model: CardlQ Function, 510(k) # K013422 * Man… | 2001 |
| * | K013422 | Cardiq FunctionSummary page 1…* Model: CT/PET Fusion, 510(k) # K010336 * Manufacturer: GE Medical Systems SCSB France * Model: CardlQ Function, 510(k) # K013422 * Manufacturer: GE Healthcare, 3200 North Grandview Blvd, Waukesha, WI 53188 USA · Model: EC-oobox… | 2001 |
| * | K040141 | Emory Cardiac Toolbox Version 2.6Summary page 1…k) # K013422 * Manufacturer: GE Healthcare, 3200 North Grandview Blvd, Waukesha, WI 53188 USA · Model: EC-oobox with HeartFusion, 510(k) # K040141 · Manufacturer: Syntermed, INC, USA * Model: Advanced Vessel Analysis II, 510(k) # K060779 * M… | 2004 |
| * | K060779 | Advance Vessel Analysis IISummary page 1…EC-oobox with HeartFusion, 510(k) # K040141 · Manufacturer: Syntermed, INC, USA * Model: Advanced Vessel Analysis II, 510(k) # K060779 * Manufacturer: GE Medical Systems SCS, Buc, France Device Description: CardIQ Fusion is a post processing… | 2006 |
What descends from it? (51)
See all 514 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 10 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K103465 (Fujifilm Medical Systems U.S.A, Inc., 2011) has gone furthest, with 20 descendants of its own.
- 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.
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?
CardlQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardlQ Fusion isa software…
Read the full statement (272 words)
CardlQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.
CardlQ Fusion isa software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
With CardlQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardlQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. 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 vessel, measure areas of abnormalities within a vessel (like stenosis, plaque).
Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner, or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061370: Cardiq Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061370
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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