FDA-Device2019-05-01Class II
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Carestream Health, Inc.
Hazard
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
Sold states
Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.
Affected count
37 units
Manufactured in
1049 W Ridge Rd, N/A, Rochester, NY, United States
Products
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2019Don't want to check this manually?
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