Device Recall INTIO Inc. ClearStartSVM

  • Modèle / numéro de série
    INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
  • Description du dispositif
    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Intio Inc, 325 Interlocken Pkwy, Broomfield CO 80021-3497
  • Société-mère du fabricant (2017)
  • Source
    USFDA