Cleared Traditional

GE DISCOVERY ST SYSTEM

K041220 · GE Medical Systems · Radiology
Jun 2004
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K041220 is an FDA 510(k) clearance for the GE DISCOVERY ST SYSTEM, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on June 15, 2004, 36 days after receiving the submission on May 10, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K041220 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2004
Decision Date June 15, 2004
Days to Decision 36 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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