510(k) Report

Devices descending from K002807

1,072 later devices reach 3D Organ Assessment W/ Magnetic Position Sensing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K163505Arietta PrecisionHitachi, Ltd.20170—
+10K163443Interson USB Ultrasound SystemInterson Corporation20173—
+10K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+10K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+10K162583Aloka Lisendo 880Hitachi, Ltd.201602
+10K163020Xperius Ultrasound SystemPhilips Health Care201611
+10K162549Lumify Ultrasound SystemPhilips Health Care2016436
+10K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+10K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+10K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+10K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+10K152195Logiq S8GE Healthcare201557—
+10K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+10K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+10K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+10K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+10K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+10K150949FibroScanEchosens201542—
+10K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+10K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+10K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+10K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+10K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+10K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+10K131527Logiq S8GE Healthcare2013219—
+10K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+10K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+10K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+10K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+10K120741Voluson S6, Voluson S8GE Healthcare2012295—
+10K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+11K262390BoneXpertVisiana20260—
+11K253452Accuro 3SRivanna Medical, Inc.20260—
+11K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+11K254021Accuro XVRivanna Medical, Inc.20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+11K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250914MediAI-BACrescom Co., Ltd.20250—
+11K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+11K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+11K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+11K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+11K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+11K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+11K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K233734Interson USB Ultrasound SystemInterson Corporation20230—
+11K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+11K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+11K231764Ultrasound System 1300Bk Medical Aps202301
+11K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+11K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+11K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+11K222441Ultrasound System 2300Bk Medical Aps20221—
+11K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+11K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+11K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+11K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+11K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+11K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+11K2116563D Echo v1.1Jointvue, LLC20210—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+11K201693DC-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—
+11K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+11K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+11K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+11K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+11K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+11K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+11K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+11K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+11K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+11K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+11K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+11K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+11K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+11K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+11K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+11K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+11K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+11K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+11K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—