Cleared Traditional

RCT700

K160525 · Ray Co., Ltd. · Radiology
Jun 2016
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K160525 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 June 20, 2016, 116 days after receiving the submission on February 25, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K160525 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2016
Decision Date June 20, 2016
Days to Decision 116 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.