# K222219: R2 Studio Q/RCT820

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Dec 6, 2022 after 134 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: 13 generations back to K973642 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192737: RCT800, Ray Co., Ltd. (2019) Summary page 4.

## Indications for use
R2 STUDIO Q/RCT820 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

Source page: https://510kreport.com/device/K222219
Methodology: https://510kreport.com/methodology