510(k) · Cleared
ClearedAdvantage 4D Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 30, 2003 as substantially equivalent to K022919 (GE Medical Systems, 2002) and 1 other predicate after a 38-day review. Its family tree reaches back 5 generations to 1995. 1 of the 224 devices in its family, counting itself, has a Class I recall. 216 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 38 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945512 (1995). 7 ancestors in all. 216 later devices descend from it, 4 citing it directly. 1 of the 224 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 4 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 3 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 2 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 1 generation backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- This deviceK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- Descendant · cites it directly · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 216 · See all- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · cites it directly200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 2 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · 2 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −4 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −3 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| +1 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 1 |
| 2026 | 23 | 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? (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 |
|---|---|---|---|
| * | K022919 | Smart Breath Respiratory Compensation OptionSummary page 2…l as devices currently on the market. GE considers features and technology of the Advantage 4D Option to be equivalent to those of Smart Breath Respiratory Compensation OK022919 and Advantage Sim 6.0 DK02 1780. Pa… | 2002 |
| * | K021780 | Advantage Sim 6.0Summary page 2…COM Radiation Therapy Structure Sets and can be used for target or treatment volume verification. This new capability comes from features derived from Advantage Sim 6.0 (K021780). Indications for Use: Advantage 4D is a non-invasive software I hardware option that can be used to provide and display CT imag… | 2002 |
What descends from it? (216)
See all 2164 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 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K091373 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 200 descendants of its own.
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?
Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032915: Advantage 4D Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032915
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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