# K060640: Digirex Digital Dental Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Dentamerica
- Decided: Apr 24, 2006 after 45 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 K925094 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031448: RSV (Radiology System Visiodent, Visiodent SA (2003) Summary page 1.
- K030647: Eva Digital Dental X-Ray System, Afp Imaging Corp. (2003) Summary page 1.
- K925094: Visualix Radiographic Image Detecting and Process, Gendex Corp. (1993) Summary page 1.

## Indications for use
The Digirex TM Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller alliow the images to be transferred to a computer for analysis, archiving and electronic transmission.

Source page: https://510kreport.com/device/K060640
Methodology: https://510kreport.com/methodology