Optima XR220amx, Optima XR200amx, and Brivo XR285amx

  • Modèle / numéro de série
    Serial 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.
  • Description du dispositif
    GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. || The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA