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.
Fujifilm Medical Systems U.S.A., Inc.
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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