510(k) Report

Devices descending from K010602

715 later devices reach Vectorvision Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K172886Breakaway Screw SystemParagon 2820174—
+9K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+9K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+9K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+9K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+9K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+9K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+9K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+10K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+10K252856PeekMed webPeek Health, S.A.20251—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K251078AutoDensityEos Imaging20250—
+10K252452PeekMed webPeek Health, S.A.20250—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+10K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+10K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+10K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+10K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+10K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+10K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+10K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+10K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+10K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+10K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+10K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+10K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+10K203005Mazor XMazor Robotics, Ltd.2020141
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+10K201149CoLink Plating SystemIn2bones USA, LLC20200—
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+10K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+10K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+10K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+10K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+10K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+10K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+11K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+11K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+11K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+11K252246Leforte MMF SystemJeil Medical Corporation20260—
+11K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+11K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+11K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+11K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+11K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+11K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+11K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+11K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+11K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—