# K073365: Dental Digital X-Ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Apr 8, 2008 after 130 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: 1 generation back to K990528 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990528: Orthophos 3/3 Ceph/3 DS, Sirona Dental Systems GmbH (1999) Summary page 1.
- K001439: Orthoceph OC100 D, Instrumentarium Corp. (2000)

## Most influential descendants
- K100317: Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo (2010), 0 descendants of its own

## Indications for use
PaX-P&P is a digital x-ray system that uses a high resolution CCD detector for real time digital image acquisition. The system allows lower radiation dose, simple user interface, and produces high quality images. It is intended for producing diagnostic x-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K073365
Methodology: https://510kreport.com/methodology