Cleared Traditional

MODIFICATION TO GE DISCOVERY LS SYSTEM

K040172 · GE Medical Systems · Radiology
Apr 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K040172 is an FDA 510(k) clearance for the MODIFICATION TO 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 April 7, 2004, 72 days after receiving the submission on January 26, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K040172 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2004
Decision Date April 07, 2004
Days to Decision 72 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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