# K140232: Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 14, 2014 after 196 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982349 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133424: Somatom Emotion 6 CT Systems, Somatom Emotion 16, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K040665: Somatom Sensation 64 and Sensation Cardiac, Siemens Medical Solutions USA, Inc. (2004). Our reading of the summary gave K040655, FDA’s number for Swift Anterior Cervical Plate System (Depuy Spine, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SOMATOM Project P30F/ Sensation 64”.
- K040577: Somatom Project P30L, Siemens Medical Systems, Inc. (2004) Summary page 5.
- K013522: Somatom P30 CT Systems, Siemens Medical Systems, Inc. (2001) Summary page 5.

## Indications for use
The SOMATOM Emotion and SOMATOM Sensation family CT 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.)

Source page: https://510kreport.com/device/K140232
Methodology: https://510kreport.com/methodology