510(k) Report

Devices descending from K001284

751 later devices reach Stealthstation System Goldeneye Micro-Magnetic Tracking System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+10K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K233017TM Plating SystemTyber Medical, LLC20231—
+10K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+10K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+10K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+10K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+10K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+10K202307Activ FuseNewclip Technics20200—
+10K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+10K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+10K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+10K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+10K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+10K170360NAVIOBlue Belt Technologies, Inc.201717—
+10K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+10K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+10K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+11K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+11K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+11K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+11K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+11K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+11K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+11K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+11K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+11K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+11K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+11K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+11K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+11K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+11K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+11K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+11K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+11K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+11K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+11K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+11K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+11K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+11K172886Breakaway Screw SystemParagon 2820174—
+11K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+11K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+11K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+12K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+12K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+12K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+12K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+12K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+12K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+12K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+12K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—