510(k) Report

Devices descending from K911783

552 later devices reach Allegro Viewing Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192198Conformis Hip SystemConformis, Inc.2019121
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+7K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K181637DC-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—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K160420SpeqTSignostics Limited20161—
+7K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+7K143668NavioBlue Belt Technologies, Inc.201520—
+7K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+7K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+7K110911Renaissance SystemMazor Robotics, Ltd.201124—
+7K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K234030Clear Guide SCENERGYClear Guide Medical20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+8K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+8K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+8K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+8K192152DC-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—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K190206DC-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—
+8K182359HipCheckStryker Corp.20181—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+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—
+8K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+8K181574UscanEchoNous, Inc.20180—
+8K173946ADAPT for Gamma3Stryker GmbH20182—
+8K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+8K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+8K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+8K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+8K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—