510(k) Report

Devices descending from K043146

27 later devices reach Horizon Medical Imaging through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152186HealthMyne PACSHealthmyne, Inc.20157—
+1K140909Mckesson RadiologyMckesson Medical Imaging Company201404
+1K081976Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation200841
+1K070755InterworksAvreo, Inc.20071—
+1K051649Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems20051017
+2K192276Merge CardioMerge Healthcare Incorporated20190—
+2K171544Arterys ViewerArterys, Inc.20176—
+2K141556Avreo Interworks SystemAvreo, Inc.20140—
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K111945Impax Next GenerationAgfa Healthcare N.V.201122
+2K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+2K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+3K211257EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai, Co., Ltd.20211—
+3K182034Arterys MICAArterys, Inc.20183—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K111319Ibis Explorer and Markup SoftwareMedqia20116—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K232100Efai Pacs Picture Archiving and Communication System ProEver Fortune.Ai, Co., Ltd.20230—
+4K192437Arterys MICAArterys, Inc.20202—
+4K122205EXINIExini Diagnostics AB20125—
+5K203744Arterys MICAArterys, Inc.20221—
+5K191262aBSIExini Diagnostics AB20192—
+5K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+6K252539Tempus PixelArterys, Inc.20250—
+6K233998TRAQinform IQAiq Global, Inc.20240—
+6K211655aPROMISEExini Diagnostics AB20211—
+7K220590aPROMISE XExini Diagnostics AB20220—