Devices

Device Recall Stereotactic Circular Collimator

  • 모델명 / 제조번호(시리얼번호)
    848, 849, 850, 851, 852, 853, 1032, 1033, 1034, 928, 929, 930, 931, 932, 801, 802, 803, 804, 805, 980, 981, 982, 983, 984, 889, 890, 891, 892, 893, 894, 908, 909, 910, 911, 912, 833, 834, 835, 836, 837, 843, 844, 845, 846, 847, 1017, 1018, 1019, 1020, 1021, 903, 904, 905, 906, 907, 883, 884, 885, 886, 933, 935, 936, 937, 940, 974, 975, 976, 977, 978, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
  • 제품 설명
    Stereotactic Circular Collimator || Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

제조사

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA

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

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Device Recall Stereotactic Circular Collimator 3D Line stereotatic Hardware Accessories
  • 모델명 / 제조번호(시리얼번호)
    933, 935, 936, 937, 940, 843, 844, 845, 846, 847, 833, 834, 835, 836, 837, 801, 802, 803, 804, 805, 908, 909, 910, 911, 912, 889, 890, 891, 892, 893, 894, 848, 849, 850, 851, 852, 853, 974, 975, 976, 977, 978, 1032, 1033, 1034, 928, 929, 930, 931, 932, 980, 981, 982, 983, 984, 1017, 1018, 1019, 1020, 1021, 883, 884, 885, 886, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 903, 904, 905, 906, 907
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.
  • 제품 설명
    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories || The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
  • Manufacturer
    Elekta, Inc.