Cleared Traditional

NIO COLOR 2MP

K133663 · Barco N.V. · Radiology
Mar 2014
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K133663 is an FDA 510(k) clearance for the NIO COLOR 2MP, 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 25, 2014, 116 days after receiving the submission on November 29, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K133663 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2013
Decision Date March 25, 2014
Days to Decision 116 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