Cleared Traditional

TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K103182 · Genoray Co., Ltd. · Radiology

Jan 2011

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K103182 is an FDA 510(k) clearance for the TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Genoray Co., Ltd. (Orange, US). The FDA issued a Cleared decision on January 14, 2011, 78 days after receiving the submission on October 28, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K103182 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2010
Decision Date	January 14, 2011
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF