510(k) · Cleared
ClearedCT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 18, 1998 as substantially equivalent to K970980 (Elscint, Inc., 1997) after a 71-day review. Its family tree reaches back 2 generations to 1995. 1 of the 277 devices in its family, counting itself, has a Class I recall. 274 later devices descend from it.
- Decided
- Aug 18, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945512 (1995). 274 later devices descend from it, 2 citing it directly. 1 of the 277 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 1 generation backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- This deviceK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- Descendant · cites it directly · 272 of its ownK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- Descendant · 2 generations on · 217 of its ownK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- Descendant · 3 generations on · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 5 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
Showing 5 of 274 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 274 · See all- K020929Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002 · cites it directly272descendants
- K022919Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002 · 2 generations on217descendants
- K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · 3 generations on216descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 5 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −1 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| +3 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +5 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 21 | 0 |
| 2021 | 16 | 0 |
| 2022 | 27 | 0 |
| 2023 | 24 | 0 |
| 2024 | 30 | 0 |
| 2025 | 34 | 1 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K970980 | Cardiac Scoring for CT ScannersSummary page 1…s: The CT Coronary Artery Calcification Scoring (CACS) option for Advantage Windows is substantially equivalent to the currently marketed Elscint Cardiac Scoring Option (K970980). Indications for Use: CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained… | 1997 |
What descends from it? (274)
See all 2742 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020929 (GE Medical Systems, 2002) has gone furthest, with 272 descendants of its own.
- 1 other device also cites its predicate K970980.
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 CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).
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/K982004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982004: CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982004
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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