510(k) · Cleared
ClearedCardiq Function
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 Oct 30, 2001 as substantially equivalent to K000315 (GE Medical Systems, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 1 of the 451 devices in its family, counting itself, has a Class I recall. 449 later devices descend from it.
- Decided
- Oct 30, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000315 (2000). 449 later devices descend from it, 6 citing it directly. 1 of the 451 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- This deviceK013422 Cardiq FunctionGE Medical Systems · 2001
- 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 · cites it directly · 174 of its ownK023760 CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BToshiba America Medical Systems, In.C · 2002
Showing 5 of 449 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 449 · 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
- K023760CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BToshiba America Medical Systems, In.C · 2002 · cites it directly174descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| 0 (this device) | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| +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 | — |
| +1 | K023760 | CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B | Toshiba America Medical Systems, In.C | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 15 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 22 | 0 |
| 2016 | 17 | 0 |
| 2017 | 21 | 0 |
| 2018 | 25 | 0 |
| 2019 | 21 | 0 |
| 2020 | 30 | 0 |
| 2021 | 23 | 0 |
| 2022 | 38 | 0 |
| 2023 | 34 | 0 |
| 2024 | 39 | 0 |
| 2025 | 45 | 1 |
| 2026 | 37 | 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 |
|---|---|---|---|
| * | K000315 | Ventricular Analysis Toolkit OptionSummary page 1…substantially equivalent to the device listed below: Model: Ventricular Analysis Toolkit Option Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K000315 Device Description: CardIQ Function, also called CT-MASS, is a software package for the GE advantage Windows (AW) workstation.… | 2000 |
What descends from it? (449)
See all 4496 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?
The CardlQ Function is a software package that can be used in conjunction with CT Cardiac images to (semi-automatically) calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic Volumes, Stroke Volume, LV Ejection Fraction including Peak Filling and Ejection Rates, Myocardial Mass Calculations, Regional Wall Motion Display and Analysis. When interpreted by a trained physician, the software aids in assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.
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/K013422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013422: Cardiq Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013422
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026