510(k) · Cleared
ClearedCardiq Function Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 26, 2008 as substantially equivalent to K041267 (General Electric Medical Systems, 2004) and 1 other predicate after a 110-day review. Its family tree reaches back 3 generations to 2000. 29 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 110 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000315 (2000). 5 ancestors in all. 29 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 2 generations backK013422 Cardiq FunctionGE Medical Systems · 2001
- 1 generation backK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- This deviceK073153 Cardiq Function XpressGE Medical Systems SCS · 2008
- Descendant · cites it directly · 25 of its ownK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- Descendant · 2 generations on · 14 of its ownK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- Descendant · 3 generations on · 11 of its ownK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 4 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 5 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K110366Syngo.CT Cardiac FunctionSiemens AG · 2011 · cites it directly25descendants
- K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on14descendants
- K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019 · 3 generations on11descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 4 generations on9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −2 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| −1 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| 0 (this device) | K073153 | Cardiq Function Xpress | GE Medical Systems SCS | 2008 | — |
| +1 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| +2 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +3 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +4 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +5 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K041267 | Cardiq Analysis IiiSummary page 1…ent to the predicate devices listed below: Device Name IFDA Clearance GE CardIQ AnalysislIII K041 267 GE CardIQ. Function K01 3422 4. Device Description The GE Medical Systems… | 2004 |
| * | K013422 | Cardiq FunctionSummary page 1…IFDA Clearance GE CardIQ AnalysislIII K041 267 GE CardIQ. Function K01 3422 4. Device Description The GE Medical Systems CardIQ Function Xpress software is a post processing software… | 2001 |
What descends from it? (29)
See all 292 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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110366 (Siemens AG, 2011) has gone furthest, with 25 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. 2008, this device’s year, is highlighted.
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 Function Xpress is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic Images. CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic…
Read the full statement (179 words)
CardIQ Function Xpress is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic Images.
CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.
CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073153: Cardiq Function Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073153
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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