# K130224: ICT

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Jul 18, 2013 after 170 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: 4 generations back to K982349 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081022: Somatom Definition, Model as/as+, Siemens Medical Solutions USA, Inc. (2008) Summary page 1.
- K032475: Somaton Computed Tomography X-Ray Systems Sliding Gantry Option, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Indications for use
The iCT device with sliding gantry 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 plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).

Source page: https://510kreport.com/device/K130224
Methodology: https://510kreport.com/methodology