510(k) · Cleared
ClearedSyngo Inspace 4D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 3, 2005 as substantially equivalent to K011447 (Siemens Medical Solutions USA, Inc., 2001) after a 49-day review. Its family tree reaches back 4 generations to 1995. 1 of the 226 devices in its family, counting itself, has a Class I recall. 218 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954355 (1995). 7 ancestors in all. 218 later devices descend from it, 5 citing it directly. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 3 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 2 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 1 generation backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- This deviceK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · cites it directly · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · cites it directly · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- Descendant · cites it directly · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 2 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 218 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…5 generations on · 2025
Most influential descendants
Showing 5 of 218 · See all- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · cites it directly210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · cites it directly172descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · cites it directly169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 2 generations on168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −3 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −2 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| 0 (this device) | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +1 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +1 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| +1 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +2 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 22 | 0 |
| 2021 | 9 | 0 |
| 2022 | 20 | 0 |
| 2023 | 18 | 0 |
| 2024 | 20 | 0 |
| 2025 | 24 | 1 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K011447 | IN Space 3DSummary page 2…Manufacturer Product 510(k) Clearance date Siemens InSpace 3D K011447 Aug. 03, 2001 (Remark: The current trade name of this software package is InSpace4D. This modificati… | 2001 |
What descends from it? (218)
See all 2185 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 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K071513 (Siemens Medical Solutions, 2007) has gone furthest, with 210 descendants of its own.
- 4 other devices also cite its predicate K011447.
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?
syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. InSpace can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the…
Read the full statement (155 words)
syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.
InSpace can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).
The goal is to visualize the blood vessels without other interfering anatomical structures.
The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043469: Syngo Inspace 4D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043469
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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