Regulatory Requirements - GE Senographe 2000 D Operator's Manual

GE Healthcare
REV 1
This product complies with the regulatory requirements of the following:
Council Directive 93/42/EEC concerning medical devices: the
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testifies compliance to the Directive.
For a system, the location of the CE marking label is described in the system manual.
European registered place of business:
GE Medical Systems Europe
Quality Assurance Manager
BP 34
F 78533 BUC CEDEX France
Tel: +33 (0)1 30 70 40 40
Code of Federal Regulations Title 21, Subchapter J – Radiological Health.
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Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
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Canadian Standards Association (CSA).
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International Electrotechnical Commission (IEC), international standards organization, when
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applicable.
Compliance with these standards is evidenced by the presence of the appropriate labels on the
exterior of the Generator cabinet.
USA/HHS:
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United States Federal law restricts this device to use by or on the order of a
CAUTION
physician.
General Electric Medical Systems is ISO 9001 and EN 46001 certified.
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The original document was written in English.
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Use within the patient environment
All components of the Senographe 2000 D system (Generator Cabinet, Gantry, Acquisition
WorkStation Cart) are designed to be suitable for use within the patient environment, and are
compliant with the relevant standards (UL 2601, IEC 601.1.1).
IMAGE ANNOTATIONS
Note: Since the equipment allows the physician to store information on the patient with the function
IMAGE ANNOTATIONS, the European Directive regarding "the protection of the people with
regard of data management on their private life and to the free circulation of these data" requests
to the computerized file users (radiologists, physicians) not to store data related to their:
– race,
– philosophical opinions,
– religious opinions,
– political opinions,
– etc.

REGULATORY REQUIREMENTS

1
Senographe 2000 D Acquisition System
label affixed to the product
0459
OM 5179217–1–100