510(k) Report

Devices descending from K911783

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+10K202749ADAPT for Gamma3Stryker GmbH20200—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+10K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+10K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+10K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K170360NAVIOBlue Belt Technologies, Inc.201717—
+10K163221Mazor XMazor Robotics, Ltd.201719—
+11K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+11K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+11K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+11K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+11K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+11K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+11K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+11K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+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—
+11K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+11K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+11K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+11K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+11K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+11K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+11K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+11K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+11K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+11K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+11K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+11K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+11K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+11K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+11K180307Mazor XMazor Robotics, Ltd.201817—
+11K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+11K172522Mazor XMazor Robotics, Ltd.20170—
+12K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+12K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+12K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+12K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+12K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+12K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+12K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+12K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+12K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+12K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+12K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+12K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+12K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+12K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+12K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+12K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+12K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+12K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+12K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+12K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+12K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+13K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+13K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+13K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—