Medical Device Directive
Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 i-ii
Operator Manual © 2010 General Electric Company. All rights reserved.
Medical Device Directive
This product complies with the following requirements:
Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of con-
formity:
The location of the CE mark label on the equipment is in the service system manual.
European registered place of business:
GE Healthcare SCS
Quality Assurance Manager
283 rue de la Minière
78530 BUC France
Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK).
Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration,
Department of Health, USA).
Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
Canadian Standards Association (CSA).
International Electrotechnical Commission (IEC), international standards organization, when applicable.
GE Healthcare reserves the right to make changes in specifications and features shown herein, or dis-
continue the product described at any time without notice or obligation.
The original language of this manual is English.
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