# K130432: PHT-6500, PHT-60CFO

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: May 31, 2013 after 99 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K973642 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122606: PHT-6500; PHT-60CFO; Pax-I3D, Mtechgroup (2012) Summary page 2.

## Indications for use
PHT-6500 (PHT-6OCFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 3600 rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians..

Source page: https://510kreport.com/device/K130432
Methodology: https://510kreport.com/methodology