Device Recall Imalux Niris OCT Imaging System Probe

  • Modèle / numéro de série
    Model Number 1300, Serial Number F464019
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution only to Texas.
  • Description du dispositif
    Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH || The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Imalux Corporation, 1771 E 30th St, Cleveland OH 44114-4407
  • Société-mère du fabricant (2017)
  • Source
    USFDA