510(k) Report

Devices descending from K012211

333 later devices reach Efilm Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+5K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+5K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20132—
+5K123302IB ClinicImaging Biometrics, LLC20131—
+5K120196Olea SphereOlea Medical201251—
+5K120115OrthosizeOrthosize, LLC201201
+5K111161Perfscape V2.0Olea Medical201153—
+5K111019Surgimap (TM) SpineNemaris, Inc.201151—
+5K092102Nordicbrainex Software, Version 1.0Nordicimaginglab AS200901
+5K081556Cadstream, Version 5.0Confirma, Inc.20099—
+6K261861SPINEsim v1.0Mdsim S.A.20260—
+6K2613522D Hip Planning SoftwareOne Ortho20260—
+6K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+6K251410VXvueVieworks Co., Ltd.20250—
+6K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+6K251038Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd.20250—
+6K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+6K241425AspenViewAspen Imaging Healthcare, Inc.20250—
+6K242270OrthoNext Platform SystemOrthofix Srl20240—
+6K243209nordicMEDiVANordicneurolab AS20240—
+6K240243EConsole2DRTECH Corporation20240—
+6K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+6K241608nordicMEDiVANordicneurolab AS20241—
+6K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+6K231498TraumaCad NeoBrainlab, Ltd.20231—
+6K230252OFIX MIS AppOrthofix US, LLC20230—
+6K230918MasterX 800 SeriesMedicatech USA20230—
+6K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+6K223841KBA3DS.M.A.I.O20231—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K213272Formus HipFormus Labs, Ltd.20230—
+6K221725Advanced MyHip PlannerMedacta International S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K222767PeekMed web (v1)Peek Health, S.A.20228—
+6K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+6K213922FX SPSPixee Medical20222—
+6K221426Functional MR V1.0Olea Medical S.A.S.202201
+6K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+6K213057ExamVue DuoJpi Healthcare Co, Ltd.20220—
+6K210344inVisionOSPrecisionos Technology, Inc.20210—
+6K211356GIQuantMotilent, Ltd.20210—
+6K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+6K202808Brainance MDAdvantis Medical Imaging Single Member P.C.20211—
+6K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+6K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+6K210556Preview ShoulderGenesis Software Innovations20213—
+6K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+6K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+6K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+6K192011PhoeniXSedecal., Sa.20198—
+6K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K191188ASHK100GLg Electronics20192—
+6K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd.20190—
+6K182537RADMAX Digital Imaging SoftwareDRGEM Corporation20190—
+6K183478ClearON MobileRayence Co., Ltd.20190—
+6K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+6K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+6K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+6K171754NovaPACSNovarad Corporation201741
+6K170729Examion X-AQSExamion GmbH20170—
+6K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+6K170172UNiD Spine AnalyzerMedicrea International20177—
+6K170195QuantXQuantitative Insights, Inc.20174—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+6K162687Paragon 2Meridian Medical Systems, LLC20160—
+6K161479hipEOSOnefit Medical20169—
+6K160407spineEOSOnefit Medical20166—
+6K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+6K143368GenIQGe Medical Systems, LLC20150—
+6K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+6K140825Delworks DR SystemDel Medical, Inc.20147—
+6K132095Olea SphereOlea Medical201320—
+6K121447Ischema View RapidIschemaview, Inc.201329—
+6K092954Cadstream Version 5Confirma, Inc.200983
+7K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+7K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+7K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+7K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+7K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+7K252214AIAS CephalonMetamorphosis GmbH20250—
+7K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K243697MySpine WebPlannerMedacta International S.A.20250—
+7K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K240926PeekMed webPeek Health, S.A.20246—
+7K242709JLK-PwiJLK, Inc.20240—
+7K242556JLK-CTPJLK, Inc.20240—
+7K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+7K240172Preview ShoulderGenesis Software Innovations20240—
+7K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+7K231662Aid-UIaid20241—
+7K231130TumorSight VizSimBioSys, Inc.20232—