# K160458: BI Image-X Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Radiotecnologia Industrial S.A. DE C.V.
- Decided: Jun 20, 2016 after 122 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
Longest line of descent: 1 generation back to K122582 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122582: Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C), Denterprise International, Inc. (2012) Summary page 5.

## Indications for use
The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.

Source page: https://510kreport.com/device/K160458
Methodology: https://510kreport.com/methodology