GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM— 510(k) K030199

Name: FDA 510(k) clearance K030199
Creator: U.S. Food and Drug Administration
Published: 2003-02-11

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K030199 for GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM, Substantially Equivalent on 2003-02-11. 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: 2003-01-21
Decision date: 2003-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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