Cleared Traditional

GE VIEWPOINT

K050943 · General Electric Co. · Radiology
May 2005
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K050943 is an FDA 510(k) clearance for the GE VIEWPOINT, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on May 23, 2005, 39 days after receiving the submission on April 14, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K050943 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2005
Decision Date May 23, 2005
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050