GE Discovery NM/CT670; GE Discovery NM 630

  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # 21058, 21002, 21013, 21017, 21020, 21029, 21039, 21041, 21049, 21066, 21075, 21079, 21080, 21081, 21082, 21119, 21140, 21144, 21145, 21147, 21150, 96BH8, 21001, 21008, 21034, 21050, 21056, 21104, 21132, 22003, 22020, 22038, 210088, 21042, 21048, 21061, 21077, 21085, 21094, 21115, 21122, 21123, 21137, 21143, 22051 21005, 21072, 21028, 21052, 21076, 21083, 21092, 21101, 21113, 21118, 21131, 21138, 21024, 22001, 22011, 22023, 21019, 21055, 21154, 83BH6 /000, 21007, 21047, 21009, 21021, 21022, 21033, 21035, 21037, 21063, 21064, 21067, 21070, 21073, 21086, 21095, 21121, 21128, 21134, 21141, 21146, 21152, 21153, 22014, 22016, 21003, 21006, 21010, 21027, 21036, 21043, 21046, 21051, 21084, 21108, 21116, 21120, 21124, 21133, 22015, 22028, 21093, 21158, 22021, 21031, 21129, 00ME1, 21004, 21014, 21053, 22005, 21012, 21059, 21151, 22022, 22031, 22035, 21089, 21100, 21136, 22044, 22071, 81BH0 /000, 82BH8 /000, 92BH7 /000, 93BH5 /000, 94BH3, 21016, 21040, 21060, 21103, 21125, 22037, 21038, 22008, 21068, 21126, 22009, 21026, 21011, 21018, 21025, 21071, 21090, 21109, 21110, 21130, 21142, 21160, 21096, 21107, 21091, 21099, 21000, 21023, 21030, 21032, 21044, 21045, 21054, 21062, 21065, 21069, 21074, 21105, 21111, 21114, 21127, 21149, 22002, 22004, 22007, 22010, 22012, 22017, 22018, 22024, 22025, 22026, 22027, 22029, 22030, 22032, 22033, 22034, 22036, 22039, 22040, 22041, 22042, 22043, 22045, 22046, 22047, 22048, 22049, 22050, 22052, 22053, 22054, 22056, 22057, 22059, 22064, 22067,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) in the states of: AL, CA, FL, GA, IL, IN, KS, LA, MD, MA, MN, MS, MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV. AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL,ITALY, JAPAN, REPUBLIC OF KOREA, NETHERLANDS,NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TAIWAN,THAILAND, TURKEY, UNITED KINGDOM.
  • 제품 설명
    GE Discovery NM/CT670; GE Discovery NM 630 || Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
  • Manufacturer
  • 1 Event

제조사

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