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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K160108
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Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110,... 2 03/20/2025 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web base... 2 04/02/2021 Fujifilm Medical Systems U.S.A., Inc.
Synapse PACS Software Versions 5.1 and higher 2 01/17/2021 Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synap... 2 06/30/2020 Fujifilm Medical Systems U.S.A., Inc.
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