GE Healthcare MRI systems with Confirmas CADstream

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, ISLAMIC IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA REPUBLIC, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, UNITED KINGDOM, UZBEKISTAN, VENEZUELA and VIETNAM.
  • 제품 설명
    Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) || Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA