Devices

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

  • Model / Serial
    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032445HL9 00000041438HL3 00000020291HL1 00000022496HL4 00000031644HL8 00000031519HL2 00000034687HL4 00000034689HL0 00000039778HL6 00000039971HL7 00000038285HL3 00000039972HL5 00000031725HL5 00000030528HL4 00000030156HL4 00000031645HL5 00000032445HL9 00000030660HL5 00000034792HL2 00000029168HL2 00000029169HL0 00000019386HL2 00000017070HL4 00000018648HL6 00000023582HL0 00000023641HL4 00000023704HL0 00000023705HL7 00000023933HL5 00000024603HL3 00000024604HL1 00000024687HL6 00000024793HL2 00000024931HL8 00000025463HL1 00000025466HL4 00000028267HL3 00000029010HL6 00000029201HL1 00000030154HL9 00000031827HL9 00000032769HL2 00000033111HL6 00000033889HL7 00000034266HL7 00000034330HL1 00000034408HL5 00000034588HL4 00000034589HL2 00000034830HL0 00000035067HL8 00000035168HL4 00000035210HL4 00000035847HL3 00000035926HL5 00000036143HL6 and 00000037383HL7.
  • 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 Revolution XR/d. Model #'s 2259988-2 & 2351505. || GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. It is intended to replace radiographic films/screen systems in all general purpose diagnostic procedures. 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

2 devices with a similar name

Learn more about the data here

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
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