510(k) · Cleared
ClearedSmartscore 3.5; Smartscore 4.0; Smartscore 4.5
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 Apr 3, 2002 as substantially equivalent to K982004 (General Electric Co., 1998) after a 12-day review. Its family tree reaches back 3 generations to 1995. 1 of the 276 devices in its family, counting itself, has a Class I recall. 272 later devices descend from it.
- Decided
- Apr 3, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945512 (1995). 272 later devices descend from it, 5 citing it directly. 1 of the 276 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 2 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 1 generation backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- This deviceK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- Descendant · cites it directly · 217 of its ownK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- Descendant · 2 generations on · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 4 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 272 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 272 · See all- K022919Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002 · cites it directly217descendants
- K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · 2 generations on216descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 4 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −2 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −1 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| 0 (this device) | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| +1 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| +2 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage WindowsSummary page 1…ly equivalent to the device listed below: Model: CT Coronary Artery Calcification Scoring (CACS) Manufacturer: General Electric Medical Systems, Milwaukee, W1 510(k) #: K982004 Device Description: SmartScore 3.5/4.0/4.5 are a family of software options that runs on the Advantage Windows (AW) (K960613) wo… | 1998 |
What descends from it? (272)
See all 2725 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022919 (GE Medical Systems, 2002) has gone furthest, with 217 descendants of its own.
- 1 other device also cites its predicate K982004.
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?
SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020929
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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