510(k) Report

Devices descending from K970617

380 later devices reach CT-Modeller System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120956VSP SystemMedical Modeling, Inc.201228—
+1K033849Simplant SystemMaterialise NV2004379—
+2K212570OsteoPlan SystemOsteomed, LLC20221—
+2K192282MedCAD® AccuPlan® SystemMedcad20203—
+2K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+2K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+2K133320Sicat FunctionSicat GmbH & Co. KG20142—
+2K133907VSP SystemMedical Modeling, Inc.201481
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K113543ONDEMAND3DCybermed, Inc.20119—
+2K113404Dental 3D Planning SoftwareSymbyo Dental, LLC20111—
+2K103723Sicat Implant V1.2Sicat GmbH & Co. KG20115—
+2K093090Galileos Implant, Version 1.7Sicat GmbH & Co. KG20090—
+2K090119Sicat ImplantSicat GmbH & Co. KG20098—
+2K073449SurgicaseMaterialise NV2008143—
+2K073468MimicsMaterialise NV2008141—
+2K071636Codiagnostix (R) 5.72Ivs Solutions AG2007212
+2K070803InvivodentalAnatomage, Inc.200738—
+2K070464ONDEMAND3DCybermed, Inc.200714—
+2K061472Galileos Implant, V 1.0Sicat GmbH & Co. KG200610—
+2K0609503MATICMaterialise NV200631—
+2K052424MaxilimMedicim NV200617—
+2K060267Virtual Implant Placement (Vip) Dental Implant Surgery Planning SoftwareImplant Logic Systems, Ltd.200643—
+2K053592Simplant DR. JamesMaterialise NV200668—
+2K053155VimplantCybermed, Inc.200563—
+2K051392Bti-Scan, Version 4.0B.T.I. Biotechnology Institute, Sl.20050—
+2K050341Implant Location Software, Model 0.1.0Tactile Technologies, Ltd.20050—
+2K042212ImplantmasterI-Dent200444—
+3K223427Mimics Enlight CMFMaterialise NV20240—
+3K231520tmCMF SolutionTechmah Cmf20231—
+3K223024MedCAD AccuPlan SystemMedcad20230—
+3K222195aprevo® Digital WorkflowCarlsmed, Inc.20221—
+3K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+3K193499DigiGuide SystemProtomed, Inc.20200—
+3K192192VSP System3D Systems20203—
+3K183676DentiqAir3D Industrial Imaging Co., Ltd.20190—
+3K192348SICAT Implant V2.0Sicat GmbH & Co. KG201901
+3K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+3K183105Mimics MedicalMaterialise NV201934—
+3K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+3K173083Implanter Dental Planning SoftwareImplanter, LLC20180—
+3K173619Mimics inPrintMaterialise NV201813—
+3K180262SICAT EndoSicat GmbH & Co. KG20180—
+3K170180Will3DHdx Will Corp.20171—
+3K161841D2P3D Systems, Inc.20178—
+3K161634IPS CaseDesignerNobel Biocare AB20163—
+3K151285VSP Cranial System3D Systems, Inc.20160—
+3K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+3K152661HICAT AirHicat GmbH20150—
+3K142779Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd.201542
+3K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K132773Sidexis 4Sirona Dental Systems GmbH20131—
+3K132636Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc.201314—
+3K130242Maven ProNsequence20130—
+3K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+3K130724Codiagnostix Implant Planning SoftwareStraumann USA201315—
+3K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+3K123976NobelclinicianNobel Biocare AB20133—
+3K123519Invivo DentalAnatomage, Inc.201324—
+3K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+3K111863Signature Planner,Signature GuidesMaterialise NV201271—
+3K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+3K113599Surgicase ConnectMaterialise NV20124—
+3K112251Swissmeda Dental Planning SystemSwissmeda AG20124—
+3K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd.201140—
+3K111641Surgicase Orthognathic Software WizardMaterialise NV20116—
+3K110300Simplant 2011Materialise Dental NV201120—
+3K102795Signature Planner; Signature GuidesMaterialise NV2011994
+3K103182Triana, Picture Archiving and Communications SystemGenoray Co., Ltd.20110—
+3K102684Xelis DentalInfinitt Co., Ltd.20102—
+3K093269Procedure Rehearsal StudioSimbionix, Ltd.201041—
+3K090607Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC20092—
+3K081402Simplant Ortho ; Vistadent 3DMaterialise Dental NV20087—
+3K070713Implant Location Software-TTactile Technologies, Ltd.20070—
+3K061126AccurexCybermed, Inc.20063—
+4K254214OoopdsTaiwan Main Orthopaedic Biotechnology Co., Ltd.20260—
+4K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+4K251964Mimics Thoracic PlannerMaterialise NV20260—
+4K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+4K242647MySegmenter (v2.0.0)Mysegmenter Technologies, Inc.20250—
+4K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+4K242599aprevo® Digital PlanningCarlsmed, Inc.20240—
+4K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+4K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20243—
+4K233874tmCMF SolutionTechmah Cmf20240—
+4K232698NemoScanSoftware Nemotec S.L.20240—
+4K231955aprevo® Digital SegmentationCarlsmed, Inc.20231—
+4K230540Patient Specific Planning Solution™ 3D Bone ModelsBiomet Manufacturing Corp20230—
+4K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K222987Akunah REFLECTAkunah Pty, Ltd.20231—
+4K220649ElucisRealize Medical, Inc.20230—
+4K222577TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc.20230—
+4K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+4K220648OMF ASP SystemVha Dean20220—
+4K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20224—
+4K213684SurgiCase ViewerMaterialise NV20221—
+4K2202053D Anatomic ModelsRicoh USA, Inc.20221—
+4K211966Segment 3DPrintMedviso AB20220—