Cleared Traditional

RCT800

K192737 · Ray Co., Ltd. · Radiology
Oct 2019
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K192737 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 October 22, 2019, 25 days after receiving the submission on September 27, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K192737 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2019
Decision Date October 22, 2019
Days to Decision 25 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.