GE Healthcare Discovery and Optima

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Radiology Devices

2

No

Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.

GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. || Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.