FDA-Device2014-10-08Class II
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Philips Medical Systems (Cleveland) Inc
Hazard
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Sold states
Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.
Affected count
79
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2711-2014Don't want to check this manually?
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