# K123419: Eva Select Digital Dental Imaging System

- Pathway: 510(k) (Special)
- Applicant: Afp Imaging Corp.
- Decided: Dec 27, 2012 after 51 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- 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: 5 generations back to K933455 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030647: Eva Digital Dental X-Ray System, Afp Imaging Corp. (2003) Summary page 1.
- K102456: Intraoral Belsensor Gold, Takara Belmont USA, Inc. (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

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

Source page: https://510kreport.com/device/K123419
Methodology: https://510kreport.com/methodology