510(k) Report

Devices descending from K921148

1,094 later devices reach Cvis Insight Catheters for Intracardiac Use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+11K241430EchoMeasureIcardio.Ai20240—
+11K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+11K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+11K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+11K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+11K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+11K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+11K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+11K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+11K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+11K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+11K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+11K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K212100KosmosEchoNous, Inc.202101
+11K211337DC-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—
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+11K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+11K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+11K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+11K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+11K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+11K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+11K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+11K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+11K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+11K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+11K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+11K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+11K1808835D ViewerSamsung Medison Co., Ltd.20180—
+11K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+11K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+11K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+11K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+11K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+11K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+11K1725133D EchoJointvue, LLC20171—
+11K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+11K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K163505Arietta PrecisionHitachi, Ltd.20170—
+11K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K163443Interson USB Ultrasound SystemInterson Corporation20173—
+11K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+11K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+11K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K162583Aloka Lisendo 880Hitachi, Ltd.201602
+11K163020Xperius Ultrasound SystemPhilips Health Care201611
+11K162549Lumify Ultrasound SystemPhilips Health Care2016436
+11K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+11K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+11K152195Logiq S8GE Healthcare201557—
+11K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+11K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+11K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+11K150949FibroScanEchosens201542—
+11K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+11K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+11K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+11K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K131527Logiq S8GE Healthcare2013219—
+11K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+12K262390BoneXpertVisiana20260—
+12K253452Accuro 3SRivanna Medical, Inc.20260—
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K254021Accuro XVRivanna Medical, Inc.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+12K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250914MediAI-BACrescom Co., Ltd.20250—