510(k) · Cleared
ClearedCard IQ Analysis II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 26, 2002 as substantially equivalent to K003408 (GE Medical Systems, 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 1 of the 379 devices in its family, counting itself, has a Class I recall. 377 later devices descend from it.
- Decided
- Mar 26, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003408 (2000). 377 later devices descend from it, 4 citing it directly. 1 of the 379 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK003408 CT Cord IQ Option 1.0GE Medical Systems · 2000
- This deviceK020796 Card IQ Analysis IIGE Medical Systems · 2002
- Descendant · cites it directly · 331 of its ownK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- Descendant · 2 generations on · 296 of its ownK052029 Syngo CirculationSiemens AG Medical Solutions · 2005
- Descendant · 3 generations on · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
Showing 5 of 377 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 377 · See all- K041267Cardiq Analysis IiiGeneral Electric Medical Systems · 2004 · cites it directly331descendants
- K052029Syngo CirculationSiemens AG Medical Solutions · 2005 · 2 generations on296descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · 3 generations on263descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 3 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003408 | CT Cord IQ Option 1.0 | GE Medical Systems | 2000 | — |
| 0 (this device) | K020796 | Card IQ Analysis II | GE Medical Systems | 2002 | — |
| +1 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| +2 | K052029 | Syngo Circulation | Siemens AG Medical Solutions | 2005 | — |
| +3 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 13 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 17 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 24 | 0 |
| 2019 | 20 | 0 |
| 2020 | 28 | 0 |
| 2021 | 19 | 0 |
| 2022 | 31 | 0 |
| 2023 | 27 | 0 |
| 2024 | 29 | 0 |
| 2025 | 39 | 1 |
| 2026 | 32 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K003408 | CT Cord IQ Option 1.0Summary page 1…dIQ Analysis IT is substantially equivalent to the device listed below: Model: CardIQ Option 1.0 Manufacturer: General Electric Medical Systems, Milwaukee, W1 510(k) #: K003408 Device Description: CardIQ Analysis IT is a post processing software option that can be used in the analysis of CT angiography… | 2000 |
What descends from it? (377)
See all 3774 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K041267 (General Electric Medical Systems, 2004) has gone furthest, with 331 descendants of its own.
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?
CardIQ Analysis I is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
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/K020796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020796: Card IQ 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/K020796
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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