# K181452: RCT800

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: Jul 27, 2018 after 56 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: 10 generations back to K973642 (1997). 31 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160525: RCT700, Ray Co., Ltd. (2016) Summary page 6.
- K170066: Green16/Green18 (Model: PHT-65LHS), VATECH Co., Ltd. (2017) Summary page 6.

## Most influential descendants
- K182805: RCT800 (2018), 8 descendants of its own
- K192737: RCT800 (2019), 7 descendants of its own
- K182614: RCT700 (2018), 6 descendants of its own
- K213226: RCT700 (2021), 5 descendants of its own
- K230753: RCT800 (2023), 1 descendant of its own

## Indications for use
RCT800 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 heath care professionals.

Source page: https://510kreport.com/device/K181452
Methodology: https://510kreport.com/methodology