# K113341: Guideshot Option, Scenaria Whole-Body X-Ray CT System

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: May 3, 2012 after 171 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: 8 generations back to K944131 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091103: Guideshot Option for CXR4 and Eclos CT Systems, Hitachi Medical Systems America, Inc. (2009) Summary page 2.

## Indications for use
The SCENARIA Whole-body X-ray CT System with guideShot Option is a x-ray imaging device that produce cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Source page: https://510kreport.com/device/K113341
Methodology: https://510kreport.com/methodology