510(k) · Cleared
ClearedSomatom Plus
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 28, 1988 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 198 devices in its family, counting itself, has a Class I recall. 197 later devices descend from it.
- Decided
- Mar 28, 1988
- Review
- 20 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
197 later devices descend from it, 1 citing it directly. 1 of the 198 devices in this family, counting this one, has a Class I recall.
- This deviceK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- Descendant · cites it directly · 196 of its ownK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- Descendant · 2 generations on · 194 of its ownK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- Descendant · 3 generations on · 192 of its ownK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- Descendant · 4 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 5 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
Showing 5 of 197 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025
Most influential descendants
Showing 5 of 197 · See all- K982536Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998 · cites it directly196descendants
- K033832Syngo Perfusion-CTSiemens AG Medical Solutions · 2003 · 2 generations on194descendants
- K050867Syngo Body Perfusion-CTSiemens AG · 2005 · 3 generations on192descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 4 generations on169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 5 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| +1 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| +2 | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| +3 | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| +4 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +5 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 1 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (197)
See all 1971 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982536 | Perfusion CT (Computed Tomography) Software Package | 1998 | 196 |
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 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K982536 (Siemens Corp., 1998) has gone furthest, with 196 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 | — |
https://510kreport.com/device/K880965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880965: Somatom Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880965
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026