510(k) · Cleared
ClearedCardIQ Suite
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 Mar 11, 2022 as substantially equivalent to K020929 (GE Medical Systems, 2002) after a 105-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 11, 2022
- Review
- 105 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945512 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 3 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 2 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 1 generation backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- This deviceK213725 CardIQ SuiteGE Medical Systems SCS · 2022
- Descendant · cites it directly · 2 of its ownK233731 CardIQ SuiteGE Medical Systems SCS · 2024
- Descendant · 2 generations on · 1 of its ownK243672 CardIQ SuiteGE Medical Systems SCS · 2025
- Descendant · 3 generations on · 0 of its ownK253770 CardIQ SuiteGE Medical Systems SCS · 2026
- Descendant · cites it directly · 0 of its ownK252217 CT VScore+Canon Medical Informatics, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K233731CardIQ SuiteGE Medical Systems SCS · 2024 · cites it directly2descendants
- K243672CardIQ SuiteGE Medical Systems SCS · 2025 · 2 generations on1descendant
- K253770CardIQ SuiteGE Medical Systems SCS · 2026 · 3 generations on0descendants
- K252217CT VScore+Canon Medical Informatics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −3 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −2 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −1 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| 0 (this device) | K213725 | CardIQ Suite | GE Medical Systems SCS | 2022 | — |
| +1 | K233731 | CardIQ Suite | GE Medical Systems SCS | 2024 | — |
| +2 | K243672 | CardIQ Suite | GE Medical Systems SCS | 2025 | — |
| +3 | K253770 | CardIQ Suite | GE Medical Systems SCS | 2026 | — |
| +1 | K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5Summary page 5…CardIQ Suite Predicate Device Device name: SmartScore 4.0 Manufacturer: GE Medical Systems SCS 510(k) number: K020929 Regulation Number: 21 CFR 892.1750 Computed tomography X-Ray System Product Code: JAK Classifi… | 2002 |
| † | K073138 | Cardiq Express Version 2.0 | 2008 |
| † | K201034 | Syngo.CT CaScoring | 2020 |
What descends from it? (4)
2 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 27 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233731 (GE Medical Systems SCS, 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K020929.
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. 2022, 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?
CardlQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardlQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular…
Read the full statement (145 words)
CardlQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardlQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardlQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. Calcium Scoring may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213725: CardIQ Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213725
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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