510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+8K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+8K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K173940Astroid Planning App.Decimal, LLC20180—
+8K173526SENTIO MMG Gen 2Medos International SARL20182—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+8K160420SpeqTSignostics Limited20161—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141860RaystationRaysearch Laboratories AB2014175
+8K141601Iassist Knee SystemZimmer Cas20142—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+9K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+9K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+9K234030Clear Guide SCENERGYClear Guide Medical20240—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K231172ApolloKneeCorin U.S.A. Limited20230—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+9K181574UscanEchoNous, Inc.20180—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+9K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—