Cleared Special

DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION

K042257 · General Electric Co. · Radiology
Sep 2004
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K042257 is an FDA 510(k) clearance for the DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on September 8, 2004, 19 days after receiving the submission on August 20, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K042257 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2004
Decision Date September 08, 2004
Days to Decision 19 days
Submission Type Special
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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