510(k) Report

Devices descending from K033400

637 later devices reach Seno Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083740Mammodiagnost VUPhilips Medical Systems Nederland B.V.20090—
+1K080351Dexela Dex Top Mammography Workstation, Model MamwkviDexela, Ltd.20082—
+1K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+1K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050—
+1K043415Centricity Pacs SystemGe Medical Systems Information Technologies200532423
+1K043216Cadstream Version 4.0Confirma, Inc.2005263—
+1K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.200416
+1K041555Securview DX Softcopy WorkstationHologic, Inc.200416—
+1K040555Impax Client EmbraceAgfa Corp.200463
+2K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+2K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+2K112096ImagelinkComputer Programs and Systems, Inc.20110—
+2K110875Centricity PacsGE Healthcare2011610
+2K091368R2 Digitalnow HD (Digitalnow HD)Hologic, Inc.20091—
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K081168Brit Pacs SystemsBrit Systems, Inc.20090—
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K083018Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions200894
+2K081948Raypax SystemRaypax, Inc.20080—
+2K082483QuantraHologic, Inc.200825—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K081976Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation200841
+2K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+2K071492FirstviewRiverain Medical Group,Llc20070—
+2K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+2K070244AEGISSentinelle Medical, Inc.200789—
+2K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co.200684
+2K062757Xeron PacsXeron Healthcare Corp.20060—
+2K062059Aie Region of Interest Image EnhancementAdvanced Image Enhancement20060—
+2K062107Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003Hologic, Inc.200614—
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K053458WEB1000Agfa Corp.200552
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K052460Powerserver, Powerreader, Gateway and PowercacheRamsoft, Inc.20050—
+2K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+2K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+3K202700ART-PlanTherapanacea20215—
+3K190379MIM on LinuxMim Software, Inc.201914—
+3K182855ProKnow DSProknow, LLC20192—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K161959ClearView cCADClearview Diagnostics, Inc.2016131
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+3K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+3K132342XVWEBApteryx, Inc.20133—
+3K132742M-VU Breast DensityVucomp, Inc.201311—
+3K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+3K120851Communify Pacs ViewerCommunify Health, LLC20130—
+3K123530Mammography Prior Enhancement (Mpe)Hologic, Inc.20120—
+3K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+3K120472QuantraHologic, Inc.20123—
+3K111332Clarity Obp SystemElekta, Ltd.20122—
+3K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+3K111945Impax Next GenerationAgfa Healthcare N.V.201122
+3K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+3K110139Curve ImageCurve Dental, Inc.20110—
+3K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+3K101842ACIESKonica Minolta Medical & Graphic, Inc.20113—
+3K103385Securview DX Diagnostic WorkstationHologic, Inc.201191
+3K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+3K102556Volpara, Version 1.3Matakina Technology Limited201024—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+3K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+3K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+4K251880Archy Dental ImagingArchy Dental, Inc.20250—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K251363ProKnow DSElekta Solutions AB20250—
+4K233572AutofusePymedix20240—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K223800MIM – Additional TracersMim Software, Inc.20231—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K220813Art-PlanTherapanacea20224—
+4K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+4K220779XDMirada Medical, Ltd.20220—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+4K190442Koios DS for BreastKoios Medical, Inc.201912—
+4K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+4K182815XVWeb 3DApteryx, Inc.20180—
+4K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+4K180522IGTFusionIgi Technologies20180—
+4K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+4K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+4K170540DM-DensityDensitas, Inc.20187—
+4K173636VelocityVarian Medical Systems, Inc.20188—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173420Radiomics App v1.0Microsoft Corp.20174—
+4K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K152009DENSEEMAMMO v1.0Statlife20161—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—