Instrumentarium Dental, PaloDEx Group Oy

  • Adresse du fabricant
    Instrumentarium Dental, PaloDEx Group Oy, Nahkelantie 160, Tuusula Finland
  • Société-mère du fabricant (2017)
  • Source
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    Device Model Number / Sales Code: 50600-IMG;   Serial Numbers (US and Foreign): F21221 - F21641, and F21643;   Serial Numbers (US Devices): F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 - F21486, F21490 - F21519, F21525 - F21542, F21545 - F21550, F21565 - F21588, F21623 - F21628, F21636 - F21641, and F21643
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom.
  • Description du dispositif
    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. || FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.