# K151765: SOMATOM Perspective

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 25, 2016 after 269 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K982349 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113287: Somatom Perspective, Siemens Medical Solutions USA, Inc. (2012) Summary page 5.
- K133590: Somatom Perspective, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K143401: SOMATOM Definition Edge, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Recalls of this device
- Feb 15, 2018 · Class II · Z-1448-2018: 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 
- Nov 22, 2016 · Class II · Z-0921-2017: 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

## Indications for use
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.)

Source page: https://510kreport.com/device/K151765
Methodology: https://510kreport.com/methodology