Device Recall Biograph mCT Flow Edge4R

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 11002, 11005, 11006, 11008
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
  • 제품 설명
    Biograph mCT Flow Edge-4R, System Material Number 10528955. || The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA Inc., 810 Innovation Dr, Knoxville TN 37932-2562
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS: 11002, 11005, 1008
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
  • 제품 설명
    Biograph mCT Flow Edge-4R, Model Number 10528955
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 11001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
  • 제품 설명
    Biograph mCT Flow Edge-4R, Material Number 10528955 || The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
  • Manufacturer