# K091103: Guideshot Option for CXR4 and Eclos CT Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jun 15, 2009 after 60 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: 7 generations back to K944131 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040902: Hitachi Presto, Hitachi Medical Systems America, Inc. (2004) Summary page 1.
- K071806: Eclos Computed Tomography X-Ray System, Hitachi Medical Systems America, Inc. (2007) Summary page 1.

## Most influential descendants
- K113341: Guideshot Option, Scenaria Whole-Body X-Ray CT System (2012), 0 descendants of its own

## Indications for use
The CXR4 Computed Tomography System with guideShot Option are x-ray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store 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/K091103
Methodology: https://510kreport.com/methodology