Device Recall NeuViz

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution in US: CO, FL, KY, NC, SC, TN, and TX.
  • 제품 설명
    NeuViz Dual series computed Tomography Scanner System, X-Ray System || The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips And Neusoft Medical Systems Co., Ltd., Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 13 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    NeuViz 16/64 Series
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.
  • 제품 설명
    Neusoft NeuViz 64 Multi-slice CT Scanner System
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
  • 제품 설명
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 || a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version.  NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    NeuViz 64 Multi-slice CT Scanner Systems
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    NeuViz 128 Multi-slice CT Scanner System with || software version 1.0.7.4038+P06 or previous version
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution
  • 제품 설명
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: || NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, || NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version || Product Usage: || The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • Manufacturer
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