510(k) · Cleared
ClearedCardiq Analysis Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on May 27, 2004 as substantially equivalent to K020796 (GE Medical Systems, 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2000. 1 of the 336 devices in its family, counting itself, has a Class I recall. 331 later devices descend from it.
- Decided
- May 27, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000315 (2000). 4 ancestors in all. 331 later devices descend from it, 7 citing it directly. 1 of the 336 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 1 generation backK013422 Cardiq FunctionGE Medical Systems · 2001
- This deviceK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- Descendant · cites it directly · 296 of its ownK052029 Syngo CirculationSiemens AG Medical Solutions · 2005
- Descendant · 2 generations on · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 331 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 331 · See all- K052029Syngo CirculationSiemens AG Medical Solutions · 2005 · cites it directly296descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · 2 generations on263descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 2 generations on168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −1 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| 0 (this device) | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| +1 | K052029 | Syngo Circulation | Siemens AG Medical Solutions | 2005 | — |
| +2 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 14 | 0 |
| 2018 | 20 | 0 |
| 2019 | 19 | 0 |
| 2020 | 28 | 0 |
| 2021 | 17 | 0 |
| 2022 | 29 | 0 |
| 2023 | 27 | 0 |
| 2024 | 26 | 0 |
| 2025 | 35 | 1 |
| 2026 | 31 | 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? (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 |
|---|---|---|---|
| * | K020796 | Card IQ Analysis IISummary page 1…he devices listed below: Model: CardIQ Analysis 11 Manufacturer: General Electric Medical Systems, Buc, France 5 10(k) #:K020796 Model: CardIQ Function Manufacturer: General Electric 3200 N. Grandview Blvd. Waukesha, WI… | 2002 |
| * | K013422 | Cardiq FunctionSummary page 1…796 Model: CardIQ Function Manufacturer: General Electric 3200 N. Grandview Blvd. Waukesha, WI 53188 5 10(k)# K013422 NOMFICHIER PAGE 1/2 Device Description: CardIQ Analysis Ill is a post pr… | 2001 |
What descends from it? (331)
See all 3317 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052029 (Siemens AG Medical Solutions, 2005) has gone furthest, with 296 descendants of its own.
- 3 other devices also cite its predicate K020796.
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 Analysis HI is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to…
Read the full statement (113 words)
CardlQ Analysis HI is a CT image analysis software package, which allows the visualization of 2D and
3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified
and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular
function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used
to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy
and coronary vessels. CardlQ Analysis HI will run on the AW workstation, scanner operator console and
PACS system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041267: Cardiq Analysis Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041267
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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