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October 28, 2020
Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 10/28/2020 Class II PRODUCT Synapse PACS Software Version 5.6.1 – 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. Recall Number: Z-0282-2021 REASON FUJIFILM...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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