FDA-Device2014-12-24Class II
Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions USA Inc.
Hazard
Possibility for system display freeze during CT interventional procedures.
Sold states
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Affected count
1 unit
Manufactured in
810 Innovation Dr, N/A, Knoxville, TN, United States
Products
Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2015Don't want to check this manually?
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