FDA-Device2014-10-01Class II
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Philips Medical Systems (Cleveland) Inc
Hazard
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Sold states
Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
Affected count
61
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2678-2014Don't want to check this manually?
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