# K030647: Eva Digital Dental X-Ray System

- Pathway: 510(k) (Special)
- Applicant: Afp Imaging Corp.
- Decided: Mar 20, 2003 after 20 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AFP Imaging Sens-A-ray System: named in the summary without a submission number

## Most influential descendants
- K123419: Eva Select Digital Dental Imaging System (2012), 0 descendants of its own
- K060640: Digirex Digital Dental Radiography System (2006), 0 descendants of its own

## Indications for use
The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.

Source page: https://510kreport.com/device/K030647
Methodology: https://510kreport.com/methodology