FDA-Device2015-05-20Class II
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Sold states
Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
Affected count
30 units
Manufactured in
419 West Ave, N/A, Stamford, CT, United States
Products
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2015Don't want to check this manually?
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