Cleared Traditional

RCT700

K213226 · Ray Co., Ltd. · Radiology
Nov 2021
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K213226 is an FDA 510(k) clearance for the RCT700, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Ray Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on November 29, 2021, 61 days after receiving the submission on September 29, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K213226 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date November 29, 2021
Days to Decision 61 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.