# K032475: Somaton Computed Tomography X-Ray Systems Sliding Gantry Option

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 10, 2003 after 90 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: 2 generations back to K941546 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990491: Angio-CT Miyabi, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K991600: Somatom Plus 4 with Sliding Gantry Option, Siemens Corp. (1999) Summary page 2.

## Most influential descendants
- K130224: ICT (2013), 0 descendants of its own

## Indications for use
The CT device with Sliding Gantry Option 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. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).

Source page: https://510kreport.com/device/K032475
Methodology: https://510kreport.com/methodology