# K083917: X-Ray, Tomography, Computed, Dental

- Pathway: 510(k) (Traditional)
- Applicant: Suni Medical Imaging, Inc.
- Decided: Jun 2, 2009 after 154 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: 3 generations back to K973642 (1997). 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)
- K082350: PAX-500, VATECH Co., Ltd. (2008) Summary page 3.

## Indications for use
The Suni3D is a computed tomography x-ray system, which is a diagnostic x-ray system intended to produce panoramic, cephalometric, and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K083917
Methodology: https://510kreport.com/methodology