FDA-Device2016-10-26Class II
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Merge Healthcare, Inc.
Hazard
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Sold states
US Nationwide Distribution
Affected count
844 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2017Don't want to check this manually?
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