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
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+12K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+12K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+12K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+12K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+12K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K233734Interson USB Ultrasound SystemInterson Corporation20230—
+12K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+12K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+12K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+12K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+12K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K2116563D Echo v1.1Jointvue, LLC20210—
+12K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+12K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+12K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+12K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+12K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+12K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+12K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+12K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+12K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+12K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+12K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+12K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+12K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+12K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+12K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+12K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+12K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+12K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+12K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+12K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+12K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+12K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+12K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+12K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+12K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+12K170445Logiq S8GE Healthcare2017191
+12K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+12K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+12K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+12K160357TrinityKoelis20161—
+12K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+12K160524FibroScan 530 CompactEchosens201641—
+12K160182LOGIQ S7 ExpertGE Healthcare2016361
+12K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+12K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+12K143452Logiq P9, Logiq P7GE Healthcare2015131—
+12K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+12K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+12K141639Voluson S6, Voluson S8GE Healthcare2014151—
+12K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+12K133533Logiq EGE Healthcare2014149—
+12K133034Logiq F SeriesGE Healthcare2014155—
+12K133277XARIO 100Toshibamedical Systems Corporation20142—
+12K133431VENUE 50GE Healthcare201360—
+12K131937Voluson I/EGE Healthcare201335—
+12K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+12K1311184D VIEWGE Healthcare20131—
+12K122387Voluson P6, Voluson P8GE Healthcare2012201—
+12K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+13K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—