510(k) Report

Devices descending from K911783

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+8K120812RenaissanceMazor Robotics, Ltd.2012211
+8K113228Renaissance SystemMazor Robotics, Ltd.201123—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K243509Archer PSI System3D-Side20250—
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+9K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+9K230045HipCheckStryker Corp.20230—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+9K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+9K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+9K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K201693DC-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—
+9K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+9K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+9K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+9K160537NavioBlue Belt Technologies, Inc.201618—
+9K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+9K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+10K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K241470CORE Shoulder SystemLinkBio Corp.202501
+10K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+10K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+10K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+10K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+10K242223SuperSonic HepaVuSupersonic Imagine20240—
+10K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+10K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+10K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+10K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+10K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+10K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+10K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+10K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211527Exo IrisExo Imaging, Inc.20211—
+10K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—