# K250060: GT300; GT300-C

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Oct 8, 2025 after 271 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: 11 generations back to K973642 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus, Genoray Co., Ltd. (2020) Summary page 5.

## Indications for use
It is intended to produce 2D (panoramic, cephalometric) or 3D (Cone Beam Computed Tomography) images. It provides diagnostic details of the dental-maxillofacial, TMJ and SINUS for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment.

Source page: https://510kreport.com/device/K250060
Methodology: https://510kreport.com/methodology