DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION— 510(k) K042257

Name: FDA 510(k) clearance K042257
Creator: U.S. Food and Drug Administration
Published: 2004-09-08

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K042257 for DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION, Substantially Equivalent on 2004-09-08. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-08-20
Decision date: 2004-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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