# K100317: Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Mar 24, 2010 after 48 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: 2 generations back to K990528 (1999). 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)
- K073365: Dental Digital X-Ray Imaging System, VATECH Co., Ltd. (2008) Summary page 2.

## Indications for use
PaX-Primo is a digital panoramic dental X-ray imaging system that uscs a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and ofal stnuctures of the patient population targeting men. women and children. The device is opcraled and used by physicians: - dentists and X-ray tcchnolognsts

Source page: https://510kreport.com/device/K100317
Methodology: https://510kreport.com/methodology