GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.

Lote

Mfg Lot or Serial # System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

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States