510(k) · Cleared
Recalled · Class II · 2018SOMATOM Perspective
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 25, 2016 as substantially equivalent to K113287 (Siemens Medical Solutions USA, Inc., 2012) and 2 other predicates after a 269-day review. Its family tree reaches back 7 generations to 1998. It has been recalled 2 times.
- Decided
- Mar 25, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K982349 (1998). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 6 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- 1 generation backK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK151765 SOMATOM PerspectiveSiemens Medical Solutions USA, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −6 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −5 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −4 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| −3 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| −2 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| −1 | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | 3 |
| 0 (this device) | K151765 | SOMATOM Perspective | Siemens Medical Solutions USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 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.
Planning a device in JAK? 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 |
|---|---|---|---|
| * | K113287 | Somatom PerspectiveSummary page 5…Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK 510(k) #: K113287 Legally Marketed Primary Predicate Device: Product Name: SOMATOM Perspective (16 and 32 slice… | 2012 |
| * | K133590 | Somatom PerspectiveSummary page 5…assification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK 510(k) Number: K133590 Legally Marketed Secondary Predicate Device: Product Name: SOMATOM Definition Edge Propriety Trade Name: SOMATOM… | 2014 |
| * | K143401 | SOMATOM Definition EdgeSummary page 5…Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK 510(k)#: K143401 4. Substantial Equivalence: Siemens SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-eas… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2018 | Class II | Z-1448-2018 | Software design | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull… |
| Nov 22, 2016 | Class II | Z-0921-2017 | Nonconforming Material/Component | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 10 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K113287.
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. 2016, this device’s year, is highlighted.
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 Perspective system is 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. In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging…
Read the full statement (159 words)
The Siemens SOMATOM Perspective system is 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.
In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.
For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.
The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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/K151765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151765: SOMATOM Perspective.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151765
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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