510(k) · Cleared
Recalled · Class II · 2018Somatom Emotion 6 CT Systems
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 Nov 22, 2002 after a 21-day review. The FDA summary names its predicate without a number. 6 of the 131 devices in its family, counting itself, have a Class I recall. 130 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 22, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 6
- Predicates
- 0
130 later devices descend from it, 6 citing it directly. 6 of the 131 devices in this family, counting this one, have a Class I recall.
- This deviceK023687 Somatom Emotion 6 CT SystemsSiemens Medical Systems, Inc. · 2002
- Descendant · cites it directly · 87 of its ownK041166 Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 130 · See all- K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly87descendants
- K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on86descendants
- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 2 generations on85descendants
- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on83descendants
- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023687 | Somatom Emotion 6 CT Systems | Siemens Medical Systems, Inc. | 2002 | — |
| +1 | K041166 | Siemens Enhanced Imaging System | Siemens Medical Solutions USA, Inc. | 2004 | 12 |
| +2 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| +2 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| +3 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 2 | 1 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 1 |
| 2017 | 4 | 0 |
| 2018 | 6 | 1 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 12 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 13 | 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.
6 devices in this family have 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? (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 |
|---|---|---|---|
| * | — | Siemens SOMATOM Emotion Duo Named without a submission number | |
| * | — | Somatom Sensation 4 CT scanners Named without a submission number |
What descends from it? (130)
See all 1306 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2018 | Class II | Z-2472-2018 | Software design | A potential risk of unnecessary radiation exposure due to a software issue |
| Feb 1, 2018 | Class II | Z-2473-2018 | Software design | A potential risk of unnecessary radiation exposure due to a software issue |
| Feb 15, 2016 | Class II | Z-1300-2016 | Device Design | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio… |
| Mar 21, 2014 | Class II | Z-1721-2014 | Component design/selection | The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury. |
| Aug 5, 2008 | Not classified | Z-2452-2008 | Nonconforming Material/Component | Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to… |
| Sep 28, 2004 | Not classified | Z-0157-05 | Other | Calcium Scoring feature on this devices is not closing properly after patient's exams. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K041166 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 87 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 SOMATOM Emotion 6 systems are intended to produce cross-sectional images of the body
by computer reconstruction of x-ray transmission data from either the same axial plane taken at
different angles or spiral planes" taken at different angles.
("spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube,
and the simultaneous translation of the patient.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023687: Somatom Emotion 6 CT Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023687
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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