Devices

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

  • Model / Serial
    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and 00000062192HL0.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL POLAND, PANAMA, PAKISTAN, NORWAY NEW ZEALAND, NETHERLANDS , MEXICO MARTINIQUE, MALTA, MALAYSIA, LITHUANIA, LABA NON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUAM, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE FINLAND , ECUADOR, DENMARK CZECH REPUBLIC, CROATIA, COLUMBIAN, CHINA, CHILE , CANDA, BULGARIA, BRAZIL, BOSNIA, BELGIUM AUSTRIA, AUSTRALIA, and ARGENTINA.
  • Product Description
    GE Healthcare Definium 8000.Model # 5131070. || GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of human anatomy.The device is not intended for mammographic applications.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

One device with a similar name

Learn more about the data here

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
  • Model / Serial
    Serial 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SLOVENIA, SAUDI ARABIA, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, NETHERLANDS, MALTA, KUWAIT, JORDAN, JAPAN, ITALY, ISRAEL, HONG KONG, GERMANY, FRANCE, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, and AUSTRALIA.
  • Product Description
    REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS || The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
  • Manufacturer
    GE Healthcare, LLC