FDA-Device2021-02-03Class II
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Hazard
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
Sold states
US Nationwide distribution in the state of MD.
Affected count
1 unit
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2021Don't want to check this manually?
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