510(k) · Cleared
Cleared3D-Angio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 12, 1999 as substantially equivalent to K974715 (GE Medical Systems, 1998) after a 72-day review. Its family tree reaches back 2 generations to 1995. 1 of the 248 devices in its family, counting itself, has a Class I recall. 245 later devices descend from it.
- Decided
- Mar 12, 1999
- Review
- 72 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954355 (1995). 245 later devices descend from it, 1 citing it directly. 1 of the 248 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 1 generation backK974715 Advantage 3D XRGE Medical Systems · 1998
- This deviceK984634 3D-AngioSiemens Medical Corp. · 1999
- Descendant · cites it directly · 244 of its ownK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- Descendant · 2 generations on · 218 of its ownK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · 3 generations on · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · 3 generations on · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- Descendant · 3 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
Showing 5 of 245 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 245 · See all- K011447IN Space 3DSiemens Medical Solutions USA, Inc. · 2001 · cites it directly244descendants
- K043469Syngo Inspace 4DSiemens AG Medical Solutions · 2005 · 2 generations on218descendants
- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · 3 generations on210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · 3 generations on172descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −1 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| 0 (this device) | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| +1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +3 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| +3 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K974715 | Advantage 3D XRSummary page 1…graphic C-arm devices. The package is substantially equivalent to the following device: Siemens Device Name FDA Clearance Number | FDA Clearance Date GE Advantage 3D XR K974715 7/6/98 4. Device Description: The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dim… | 1998 |
What descends from it? (245)
See all 2451 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011447 | IN Space 3D | 2001 | 244 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K011447 (Siemens Medical Solutions USA, Inc., 2001) has gone furthest, with 244 descendants of its own.
- 1 other device also cites its predicate K974715.
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 3D-Angio 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 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
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/K984634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984634: 3D-Angio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984634
Report an extraction error
Are you the manufacturer?
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