Cleared Special

NIO COLOR 3MP LED

K131295 · Barco N.V. · Radiology
May 2013
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K131295 is an FDA 510(k) clearance for the NIO COLOR 3MP LED, 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 May 29, 2013, 23 days after receiving the submission on May 6, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K131295 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2013
Decision Date May 29, 2013
Days to Decision 23 days
Submission Type Special
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