Cleared Special

ClearON Mobile

K183478 · Rayence Co., Ltd. · Radiology
Mar 2019
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K183478 is an FDA 510(k) clearance for the ClearON Mobile, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on March 1, 2019, 74 days after receiving the submission on December 17, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K183478 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2018
Decision Date March 01, 2019
Days to Decision 74 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050