Cleared Traditional

K093197 - CORONIS FUSION 10MP, MODEL MDCG-10130 (FDA 510(k) Clearance)

K093197 · Barco N.V. · Radiology device

Jun 2010

Decision

257d

Days

Class 2

Risk

K093197 is an FDA 510(k) clearance for the CORONIS FUSION 10MP, MODEL MDCG-10130. This device is classified as 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 June 23, 2010, 257 days after receiving the submission on October 9, 2009.

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

Submission Details

510(k) Number	K093197 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 2009
Decision Date	June 23, 2010
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement