Cleared Traditional

GE DISCOVERY LS SYSTEM

K023988 · GE Medical Systems · Radiology
Feb 2003
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K023988 is an FDA 510(k) clearance for the GE DISCOVERY LS 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 February 4, 2003, 64 days after receiving the submission on December 2, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K023988 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2002
Decision Date February 04, 2003
Days to Decision 64 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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