Cleared Traditional

GE DISCOVERY VCT SYSTEM

K050559 · GE Medical Systems · Radiology
Mar 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K050559 is an FDA 510(k) clearance for the GE DISCOVERY VCT SYSTEM, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on March 17, 2005, 14 days after receiving the submission on March 3, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K050559 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2005
Decision Date March 17, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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