510(k) · Cleared
ClearedSyngo CT Pulmo 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 29, 2013 as substantially equivalent to K071513 (Siemens Medical Solutions, 2007) and 1 other predicate after a 283-day review. Its family tree reaches back 7 generations to 1995. 9 later devices descend from it.
- Decided
- Aug 29, 2013
- Review
- 283 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954355 (1995). 11 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 6 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 5 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 4 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 3 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 2 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 1 generation backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- This deviceK123540 Syngo CT Pulmo 3DSiemens Medical Systems, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK183271 AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK203699 syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK213713 AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2022
- Descendant · cites it directly · 1 of its ownK220450 syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK214019 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019 · cites it directly6descendants
- K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on3descendants
- K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2022 · 2 generations on1descendant
- K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. · 2022 · cites it directly1descendant
- K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −6 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −5 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −4 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −3 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −2 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −1 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| 0 (this device) | K123540 | Syngo CT Pulmo 3D | Siemens Medical Systems, Inc. | 2013 | — |
| +1 | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +2 | K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2022 | — |
| +1 | K220450 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +3 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K071513 | Inspace 4D Software Package with Extended FunctionalitySummary page 1…______ ___ ____ ___ ___Number _ _ _ _ _ _ _ _ _ _ _ Siemens syngo® InSpace 4D K071513 06/26/2007 Vida Pulmonary Workstation K083227 11/18/2008… | 2007 |
| * | K083227 | Vida Pulmonary Workstation 2 (PW2)Summary page 1…_ _ _ _ _ Siemens syngo® InSpace 4D K071513 06/26/2007 Vida Pulmonary Workstation K083227 11/18/2008 2 (PW 2) 4. Device Description: syngo.CT Pulmo 3D all… | 2008 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K183271 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K071513.
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. 2013, 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 Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lung, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles. Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung. The following evaluation tools are provided: "…
Read the full statement (119 words)
syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lung, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles.
Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung.
The following evaluation tools are provided:
" Computation of lung volumes
* Display of statistics related to the lung
* Setting of markers
* Airway measurements
syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation.
You can use syngo.CT Pulmo 3D to create a DICOM Structured Report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123540: Syngo CT Pulmo 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123540
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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