# K012355: Image-X System

- Pathway: 510(k) (Traditional)
- Applicant: Tg Group, Inc.
- Decided: Aug 9, 2001 after 15 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This extraoral source x-ray system is intended for dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K012355
Methodology: https://510kreport.com/methodology