510(k) Report

Devices descending from K112439

11 later devices reach Synapse Workstation Software Version 3.3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162145vRad PACS with MammographyVirtual Radiologic Corporation201611
+1K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+2K241879vRad ViewerVirtual Radiologic Corporation20240—
+2K190232Synapse PACSFujifilm Corporation2019311
+2K173475Merge PACSMerge Healthcare Incorporated201712
+2K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+2K163668SuitestensaEbit Srl20170—
+3K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+3K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+3K192455Merge PACSMerge Healthcare Incorporated201904
+4K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—