FDA-Device2021-06-09Class II
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Philips North America Llc
Hazard
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Sold states
Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Affected count
2 units (1 US and 1 OUS)
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2021Don't want to check this manually?
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