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 Jul 21, 2026 as substantially equivalent to K243672 (GE Medical Systems SCS, 2025) after a 237-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 21, 2026
- Review
- 237 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945512 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 5 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 4 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 3 generations backK213725 CardIQ SuiteGE Medical Systems SCS · 2022
- 2 generations backK233731 CardIQ SuiteGE Medical Systems SCS · 2024
- 1 generation backK243672 CardIQ SuiteGE Medical Systems SCS · 2025
- This deviceK253770 CardIQ SuiteGE Medical Systems SCS · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −6 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −5 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −4 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −3 | K213725 | CardIQ Suite | GE Medical Systems SCS | 2022 | — |
| −2 | K233731 | CardIQ Suite | GE Medical Systems SCS | 2024 | — |
| −1 | K243672 | CardIQ Suite | GE Medical Systems SCS | 2025 | — |
| 0 (this device) | K253770 | CardIQ Suite | GE Medical Systems SCS | 2026 | — |
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 |
|---|---|---|---|
| * | K243672 | CardIQ SuiteSummary page 6…CardIQ Suite Common/Usual Name: System, X-Ray, Tomography, Computed Manufacturer: GE Medical Systems SCS 510(k) number: K243672 Classification Name: Computed tomography X-Ray System Regulation Number: 21 CFR 892.1750 Product Code:… | 2025 |
| † | K073138 | Cardiq Express Version 2.0 | 2008 |
| † | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | 2002 |
| † | K223424 | Spine Auto Views | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
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. 2026, 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 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. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular…
Read the full statement (173 words)
CardIQ 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. CardIQ 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.
CardIQ 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. The clinician can use the information provided by calcium scoring to monitor the progression/regression of calcium in coronary arteries over time, and this information may aid the clinician in their determination of the prognosis of cardiac disease. CardIQ Suite also provides an estimate of the volume of heart fat for informational use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253770 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253770: CardIQ Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253770
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026