Devices

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

  • Modèle / numéro de série
    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and 00000037383HL7.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

GE Medical Systems, LLC
  • Adresse du fabricant
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
  • Modèle / numéro de série
    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and 00000062192HL0.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Serial 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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