Device Recall iCAT Classic (XRay Tube head and Power Supply)

  • Model / Serial
    Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
  • Product Description
    i-CAT Classic (X-Ray Tube head and Power Supply) || X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • Manufacturer Parent Company (2017)
  • Source
    USFDA