RCT700

FDA 510(k) K213226 · Ray Co., Ltd.

Substantially Equivalent

510(k) numberK213226

Submission

Device name
RCT700
Applicant
Ray Co., Ltd.
Hwaseong-Si, KR
Received
September 29, 2021
Decision date
November 29, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other 510(k)s with product code OAS

510(k)DeviceApplicantDecision
K261748Dental Cone-beam Computed Tomography (mDX-15P Series)OAS · Traditional Hefei Meyer Optoelectronic Technology, Inc.07/23/2026SE
K250839Dental X-ray SystemOAS · Traditional Changzhou Boen Zhongding Medical Technology Co.…06/11/2026SE
K260662Dental Cone Beam Computed Tomography SystemOAS · Special Yofo Medical Technology Co., Ltd.06/04/2026SE
K253935medXion NEXUSOAS · Traditional medXion Technologies, Inc.05/15/2026SE
K260462RCT800OAS · Special Ray Co., Ltd.04/09/2026SE
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special VATECH Co., Ltd.03/31/2026SE
K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE

More from Fussen Technology Co., Ltd.

510(k)DeviceDecision
K260462RCT800OAS · Special 04/09/2026SE
K251798RCT700OAS · Traditional 11/25/2025SE
K251109SMARTDentLLZ · Traditional 05/21/2025SE
K243903RCT600OAS · Traditional 03/12/2025SE
K233625Raydent SWPNN · Traditional 05/16/2024SE
K232325RAYSCAN a-ExpertMUH · Traditional 04/18/2024SE
K232287RAYSCAN a-Expert3DOAS · Special 08/31/2023SE
K230753RCT800OAS · Special 04/11/2023SE
K211105Ear-Friendly MaskFXX · Traditional 05/17/2021SE
K192737RCT800OAS · Traditional 10/22/2019SE

Questions and answers

When was RCT700 cleared by the FDA?

RCT700 (K213226) received a 510(k) decision of Substantially Equivalent on November 29, 2021, 61 days after the submission was received.

What is the product code of K213226?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.