510(k) · Cleared
Recalled · Class II · 2016Somatom Sensation 64 and Sensation Cardiac
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 Apr 2, 2004 as substantially equivalent to K013522 (Siemens Medical Systems, Inc., 2001) after a 29-day review. Its family tree reaches back 2 generations to 1998. 1 of the 139 devices in its family, counting itself, has a Class I recall. 136 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 2, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982349 (1998). 136 later devices descend from it, 6 citing it directly. 1 of the 139 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- This deviceK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 64 of its ownK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · cites it directly · 63 of its ownK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 62 of its ownK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- Descendant · 2 generations on · 53 of its ownK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 49 of its ownK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
Showing 5 of 136 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200213 Biograph mMR with syngo MR E11P-AP01 system…6 generations on · 2020
Most influential descendants
Showing 5 of 136 · See all- K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · cites it directly64descendants
- K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · cites it directly63descendants
- K081453Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008 · 2 generations on62descendants
- K103127Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on53descendants
- K130901Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014 · 3 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| 0 (this device) | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +1 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| +2 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +2 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| +3 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 1 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K013522 | Somatom P30 CT SystemsSummary page 1…commercial distribution: Predicate Device Name FDA Clearance Number FDA Clearance Date Siemens SOMATOM P30 K013522 11/07/2001 Siemens Medical Solutions, Inc. USA Page 7 S… | 2001 |
What descends from it? (136)
See all 1366 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060631 | Biograph 64 and Biograph 40 | 2006 | 64 |
| K081022 | Somatom Definition, Model as/as+ | 2008 | 63 |
| K043087 | Somatom Care Contrast CT | 2004 | 2 |
| K121792 | Neuviz 64 Multi-Slice CT Scanner System | 2012 | 1 |
| K140232 | Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT | 2014 | 0 |
| K043086 | Somatom Respiratory Gating | 2004 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2016 | Class II | Z-1306-2016 | 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… |
| Feb 15, 2016 | Class II | Z-1305-2016 | 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… |
| Sep 3, 2008 | Not classified | Z-0320-2009 | Software design | software error - does not allow protocol to properly synchronize with ECG triggers |
| Sep 3, 2008 | Not classified | Z-0321-2009 | Software design | software error - does not allow protocol to properly synchronize with ECG triggers |
| Mar 9, 2006 | Not classified | Z-0795-06 | Other | When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved. |
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.
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060631 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 64 descendants of its own.
- 4 other devices also cite its predicate K013522.
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 Siemens SOMATOM P30F 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/K040665 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040665: Somatom Sensation 64 and Sensation Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040665
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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