FDA-Device2013-08-21Class II
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Carestream Health Inc.
Hazard
Due to potential for an x-ray exposure technique change.
Sold states
Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Affected count
US: 49 units; Foreign: 183 units (revised)
Manufactured in
150 Verona St, Rochester, NY, United States
Products
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1877-2013Don't want to check this manually?
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