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
+7K083597Sonowand InviteSonowand AS20093—
+7K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+7K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+7K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+7K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+7K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+7K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+7K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+7K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+7K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+7K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+7K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+7K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+7K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+7K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+7K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005194—
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K260192DIANAROPCA ApS20260—
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K242359Strain AI (SAI001)Exo, Inc.20240—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232501AI Platform (AIP001)Exo, Inc.20231—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+8K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+8K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+8K213275EchoGo Core (2.0)Ultromics Limited20211—
+8K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+8K200603AAA ModelPhilips Ultrasound, Inc.20200—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+8K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+8K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+8K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+8K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+8K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+8K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+8K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+8K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+8K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+8K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+8K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+8K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K160420SpeqTSignostics Limited20161—
+8K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+8K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K152250SpeqRTSignostics Limited20150—
+8K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+8K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+8K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+8K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+8K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+8K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—