SPECULAR MICROSCOPE CEM530

  • Modèle / numéro de série
    Microscopes with serial numbers: 120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044,120045, 120046, 120047, 120048, 120049, 120050.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
  • Description du dispositif
    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. || Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured || images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Société-mère du fabricant (2017)
  • Source
    USFDA