510(k) Report

Devices descending from K160108

8 later devices reach Synapse PACS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190232Synapse PACSFujifilm Corporation2019311
+1K173475Merge PACSMerge Healthcare Incorporated201712
+1K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+1K163668SuitestensaEbit Srl20170—
+2K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+2K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+2K192455Merge PACSMerge Healthcare Incorporated201904
+3K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—