510(k) Report

Devices descending from K051553

19 later devices reach Fuji Synapse Workstation Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140909Mckesson RadiologyMckesson Medical Imaging Company201404
+1K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+1K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc.2011112
+1K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+1K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+1K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation20092—
+2K162145vRad PACS with MammographyVirtual Radiologic Corporation201611
+2K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+2K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091—
+3K241879vRad ViewerVirtual Radiologic Corporation20240—
+3K190232Synapse PACSFujifilm Corporation2019311
+3K173475Merge PACSMerge Healthcare Incorporated201712
+3K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+3K163668SuitestensaEbit Srl20170—
+3K171130Nucleus Image Management SystemNucleushealth, LLC20170—
+4K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+4K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+4K192455Merge PACSMerge Healthcare Incorporated201904
+5K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—