# K213226: RCT700

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: Nov 29, 2021 after 61 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). 35 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182614: RCT700, Ray Co., Ltd. (2018) Summary page 6.
- K192737: RCT800, Ray Co., Ltd. (2019) Summary page 6.

## Most influential descendants
- K230753: RCT800 (2023), 1 descendant of its own
- K260462: RCT800 (2026), 0 descendants of its own
- K251798: RCT700 (2025), 0 descendants of its own
- K243903: RCT600 (2025), 0 descendants of its own
- K242805: Dental Cone-beam Computed Tomography (FinScan F350) (2025), 0 descendants of its own

## Indications for use
RCT700 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure 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/K213226
Methodology: https://510kreport.com/methodology