# K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 23, 2015 after 86 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.
25 later devices descend from it; 3 cite it directly.
0 of 34 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 5.

## Most influential descendants
- K162660: Green Smart (Model: PHT-35LHS) (2016), 19 descendants of its own
- K170066: Green16/Green18 (Model: PHT-65LHS) (2017), 18 descendants of its own
- K181452: RCT800 (2018), 10 descendants of its own
- K182805: RCT800 (2018), 8 descendants of its own
- K192737: RCT800 (2019), 7 descendants of its own

## Indications for use
PHT-30LFO 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 360° 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/K152106
Methodology: https://510kreport.com/methodology