Cleared Traditional

RCT800

K181452 · Ray Co., Ltd. · Radiology
Jul 2018
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K181452 is an FDA 510(k) clearance for the RCT800, 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 July 27, 2018, 56 days after receiving the submission on June 1, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K181452 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2018
Decision Date July 27, 2018
Days to Decision 56 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.