Devices

XVI R4.5 Xray Volume Imaging System

  • Modelo / Serial
    105984, 151076, 151080, 151141, 151155, 151156, 151157, 151168, 151260, 151362, 151396, 151412, 151442, 151545, 151566, 151616, 151628, 151683, 151684, 151710, 151764, 151785, 151802, 151812, 151839, 151885, 151892, 151931, 151942, 151952, 151954, 151955, 152019, 152117, 152158, 152163, 152177, 152207, 152210, 152211, 152222, 152223, 152248, 152257, 152262, 152271, 152301, 152303, 152305, 152307, 152308, 152331, 152352, 152353, 152356, 152358, 152359, 152362, 152365, 152370, 152371, 152373, 152388, 152392, 152425, 152432, 152433, 152448, 152452, 152454, 152468, 152469, 152481, 152491, 152504, 152522, 152536
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico
  • Descripción del producto
    Elekta Synergy XVI R.4.5 and R4.6 || ProducT Usage: To be used as part of radiation therapy treatment process.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

Fabricante

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall XVI R4.5 Xray Volume Imaging System
  • Modelo / Serial
    152433, 152019, 151176, 152248, 152262, 152454, 105941, 151802, 152427, 151628, 151362, 152207, 151545, 151566, 152271, 152425, 152452, 152491, 151808, 152163, 152331, 151443, 151955, 152585, 152522, 151514, 151791, 151430, 151931. 105984, 151412, 152388, 151616, 151141, 152303, 151892, 151785, 152358, 152223, 152305, 152468, 151260, 152469, 152481, 152601, 152356, 152175, 152365, 152177, 152257, 151952, 152353, 152359, 152362, 152352, 152371, 152370, 151942, 151820, 151770, 151864, 151396, 152448, 151954, 151076, 151309, 152103, 152301, 151634, 151793, 152210, 152211, 151080, 152373, 152222, 152158, 152392, 151684, 152530, 152536, 151168, 151839, 151156, 151155, 151157, 152117, 151710, 152308, 152307, 152504, 151683, 151764, 151885, 152432, 151812, 152549.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico
  • Descripción del producto
    Elekta Synergy XVI 4.5 and R4.6 || To be used as part of radiation therapy treatment process.
  • Manufacturer
    Elekta, Inc.