510(k) Report

Devices descending from P050014

17 later devices reach Fuji's Computed Radiography Mammography Suite (Fcrms) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110717Konica Minolta Xpress Digital Mammography SystemKonica Minolta Medical & Graphic, Inc.20110—
+1K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc.2011112
+1K110025Sectra Microdose MammographySectra Imtec AB20113—
+2K162145vRad PACS with MammographyVirtual Radiologic Corporation201611
+2K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+2K123995Microdose SIPhilips Digital Mammography Sweden AB20131—
+2K120255Philips MicrodosePhilips Digital Mammography Sweden AB20122—
+3K241879vRad ViewerVirtual Radiologic Corporation20240—
+3K190232Synapse PACSFujifilm Corporation2019311
+3K173475Merge PACSMerge Healthcare Incorporated201712
+3K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+3K163668SuitestensaEbit Srl20170—
+3K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+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—