# K121412: Pax-FLEX3D, PHT-7000

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Jun 8, 2012 after 28 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: 5 generations back to K973642 (1997). 6 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102259: Dental Computed Tomography X-Ray System, VATECH Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K122606: PHT-6500; PHT-60CFO; Pax-I3D (2012), 27 descendants of its own
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (2015), 25 descendants of its own
- 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

## Indications for use
PaX-Flex3D 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 samne 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/K121412
Methodology: https://510kreport.com/methodology