# K043086: Somatom Respiratory Gating

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 23, 2004 after 45 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)
- K023687: Somatom Emotion 6 CT Systems, Siemens Medical Systems, Inc. (2002) Summary page 2.
- K040665: Somatom Sensation 64 and Sensation Cardiac, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K040577: Somatom Project P30L, Siemens Medical Systems, Inc. (2004) Summary page 2.

## Indications for use
Respiratory Gating is an option for CT scanner of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.

Source page: https://510kreport.com/device/K043086
Methodology: https://510kreport.com/methodology