510(k) · Cleared
Clearedsyngo.CT Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 7, 2022 as substantially equivalent to K123540 (Siemens Medical Systems, Inc., 2013) after an 18-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Mar 7, 2022
- Review
- 18 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954355 (1995). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 7 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 6 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 5 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 4 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 3 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 2 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 1 generation backK123540 Syngo CT Pulmo 3DSiemens Medical Systems, Inc. · 2013
- This deviceK220450 syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232136 syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −7 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −6 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −5 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −4 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −2 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −1 | K123540 | Syngo CT Pulmo 3D | Siemens Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K220450 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +1 | K232136 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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.
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 |
|---|---|---|---|
| * | K123540 | Syngo CT Pulmo 3DSummary page 5…1 Special 510(k): syngo.CT Applications 510(k) Number: K123540 Clearance Date: 08/29/2013 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR… | 2013 |
| † | K092013 | Syngo Volume Perfusion-CT Body | 2009 |
| † | K123584 | Syngo, CT Bone Reading | 2013 |
| † | K123585 | Syngo, CT Cardiac Function | 2012 |
| † | K173637 | syngo.CT Coronary Analysis; syngo.CT Vascular Analysis | 2018 |
| † | K150785 | syngo.CT Dental | 2015 |
| † | K120331 | Syngo CT Dynamic Angio | 2012 |
| † | K133643 | Syngo, CT Liver Analysis | 2014 |
| † | K150713 | syngo.CT Myocardial Perfusion | 2015 |
| † | K053024 | Syngo Neuro Dsa CT | 2005 |
| † | K202213 | syngo.CT Neuro Perfusion | 2020 |
| † | K203411 | syngo.CT Skull Unfolding | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232136 | syngo.CT Applications | 2024 | 0 |
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 27 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K232136 (Siemens Medical Solutions USA, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123540.
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. 2022, 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?
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: » Evaluation of perfusion of organs and tumors and myocardial tissue perfusion » Evaluation of bone structures and detection of bone lesions * Evaluation…
Read the full statement (138 words)
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.
This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:
» Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
» Evaluation of bone structures and detection of bone lesions
* Evaluation of CT images of the heart
* Evaluation of the coronary lesions
* Evaluation of the mandible and maxilla
» Evaluation of dynamic vessels and extended phase handling
» Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver
* Evaluation of neurovascular structures
» Evaluation of the lung parenchyma
» Evaluation of non-enhanced Head CT images
* Evaluation of vascular lesions
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/K220450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220450: syngo.CT Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220450
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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