Cleared Traditional

K040039 - NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM (FDA 510(k) Clearance)

K040039 · Barco N.V. · Radiology device

Mar 2004

Decision

68d

Days

Class 2

Risk

K040039 is an FDA 510(k) clearance for the NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Barco N.V. (Albuquerque, US). The FDA issued a Cleared decision on March 17, 2004, 68 days after receiving the submission on January 9, 2004.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K040039 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 2004
Decision Date	March 17, 2004
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF