510(k) · Cleared
ClearedIN Space 3D
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 Aug 3, 2001 as substantially equivalent to K984634 (Siemens Medical Corp., 1999) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1995. 1 of the 251 devices in its family, counting itself, has a Class I recall. 244 later devices descend from it.
- Decided
- Aug 3, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954355 (1995). 6 ancestors in all. 244 later devices descend from it, 5 citing it directly. 1 of the 251 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 2 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 1 generation backK984634 3D-AngioSiemens Medical Corp. · 1999
- This deviceK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 218 of its ownK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · 2 generations on · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · 2 generations on · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- Descendant · 2 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 3 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
Showing 5 of 244 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 244 · See all- K043469Syngo Inspace 4DSiemens AG Medical Solutions · 2005 · cites it directly218descendants
- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · 2 generations on210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · 2 generations on172descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 2 generations on169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 3 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −2 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −1 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| 0 (this device) | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +2 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +2 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| +2 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +3 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
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 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 15 | 0 |
| 2016 | 10 | 0 |
| 2017 | 10 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 23 | 0 |
| 2021 | 9 | 0 |
| 2022 | 21 | 0 |
| 2023 | 19 | 0 |
| 2024 | 21 | 0 |
| 2025 | 25 | 1 |
| 2026 | 18 | 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? (3)
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 |
|---|---|---|---|
| * | K984634 | 3D-AngioSummary page 5…ures(eg. Lesions, Stent implants) for diagnosis, surgical planning, interventional procedures and treatment follow-up. As with the FDA cleared 3D Angio software package(K984634), this software package will also assist the physician in diagnosis and treatment of vessel malformations(i.e. Aneurysms, AVMs a… | 1999 |
| * | K003266 | Siremobil Iso-C 3DSummary page 1…raphic C-arm devices. The package is substantially equivalent to the following device: 3D Angio Software Option : K98463 T 03/12/99 Siemens Siremobil Iso C 3D Imaging. K003266 10/18/00 Option Philips Integris 3D RA Option K983877 12/21/98 Simplified 510(k) for Siemens “In Space 3D” Angiography Software… | 2000 |
| * | K983877 | Philips Integris 3D RA OptionSummary page 1…valent to the following device: 3D Angio Software Option : K98463 T 03/12/99 Siemens Siremobil Iso C 3D Imaging. K003266 10/18/00 Option Philips Integris 3D RA Option K983877 12/21/98 Simplified 510(k) for Siemens “In Space 3D” Angiography Software 5/10/01 Page 62 of 67 Device Descripti… | 1998 |
What descends from it? (244)
See all 2445 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 6 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K043469 (Siemens AG Medical Solutions, 2005) has gone furthest, with 218 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?
The In Space 3D package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
The In Space 3D package is intended for imaging both hard and soft tissues as well as other internal body structures(eg. Lesions, Stent implants) for diagnosis, surgical planning, interventional procedures and treatment follow-up.
As with the FDA cleared 3D Angio software package(K984634), this software package will also assist the physician in diagnosis and treatment of vessel malformations(i.e. Aneurysms, AVMs and Stenoses).
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/K011447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011447: IN Space 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011447
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026