FDA-Device2016-06-29Class II
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint 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
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Sold states
Worldwide Distribution - US Nationwide
Affected count
100 units
Manufactured in
810 Innovation Dr, N/A, Knoxville, TN, United States
Products
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint 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-2031-2016Don't want to check this manually?
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