Devices

Device Recall Widefield OCT software

  • Modèle / numéro de série
    The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationally
  • Description du dispositif
    Widefield OCT software feature for the Spectralis HRA+OCT and variants
  • Manufacturer
    Heidelberg Engineering
  • 1 Event

Fabricant

Heidelberg Engineering
  • Adresse du fabricant
    Heidelberg Engineering, 10 Forge Pkwy, Franklin MA 02038-3137
  • Société-mère du fabricant (2017)
    Heidelberg Engineering Inc.
  • Source
    USFDA