510(k) · Cleared
ClearedSmart Breath Respiratory Compensation Option
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 Sep 19, 2002 as substantially equivalent to K020929 (GE Medical Systems, 2002) after a 15-day review. Its family tree reaches back 4 generations to 1995. 1 of the 222 devices in its family, counting itself, has a Class I recall. 217 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945512 (1995). 217 later devices descend from it, 1 citing it directly. 1 of the 222 devices in this family, counting this one, has a Class I recall.
- 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 deviceK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- Descendant · cites it directly · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 217 · See all- K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · cites it directly216descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
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) | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| +1 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 2…e phase selected. Comparison with Predicate: This device will use a similar technology to that already used by GE Medical Systems in our cleared device Smartscore 3.5 (K020929). Fundamentally, this device will use the same phase selection process that is used in Smartscore to group images based on cardia… | 2002 |
What descends from it? (217)
See all 2171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032915 | Advantage 4D Option | 2003 | 216 |
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 · 7 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 4 ancestors has a recall.
- Of its descendants, K032915 (Ge Medical Systems, LLC, 2003) has gone furthest, with 216 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.
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?
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022919: Smart Breath Respiratory Compensation Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022919
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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