Cleared Traditional

CORONIS 5MP

K133984 · Barco N.V. · Radiology
Mar 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K133984 is an FDA 510(k) clearance for the CORONIS 5MP, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on March 28, 2014, 92 days after receiving the submission on December 26, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K133984 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2013
Decision Date March 28, 2014
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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