Cleared Special

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

K160579 · Rayence Co., Ltd. · Radiology
Apr 2016
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K160579 is an FDA 510(k) clearance for the Xmaru View V1 and Xmaru PACS, Medical Image Processing Software, 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 April 8, 2016, 38 days after receiving the submission on March 1, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K160579 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2016
Decision Date April 08, 2016
Days to Decision 38 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