Device Recall Retcam3 & Retcam Shuttle with version

  • Modèle / numéro de série
    Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
  • Description du dispositif
    Retcam3 & Retcam Shuttle with version 6.0 software. || Clarity Medical Systems, Inc. || 5775 W. Las Positas Blvd, Suite 200 || Pleasanton, CA 94588 || General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Clarity Medical Systems Inc, 5775 W Las Positas Blvd, Pleasanton CA 94588
  • Société-mère du fabricant (2017)
  • Source
    USFDA