FDA-Device2020-06-10Class II
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Siemens Medical Solutions USA, Inc
Hazard
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
Sold states
AZ, IL, UT, WI
Affected count
5 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2020Don't want to check this manually?
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