510(k) Report

Devices descending from K010950

994 later devices reach Cypress System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+10K191171EchoGo CoreUltromics, Ltd.20193—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+10K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+10K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+10K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+10K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+10K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+10K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+10K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+10K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+10K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+10K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+10K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K1808835D ViewerSamsung Medison Co., Ltd.20180—
+10K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+10K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+10K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+10K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+10K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+10K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+10K1725133D EchoJointvue, LLC20171—
+10K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+10K170841BiopSee, Mobile USMedcom GmbH20170—
+10K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+10K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+10K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+10K163505Arietta PrecisionHitachi, Ltd.20170—
+10K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+10K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+10K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K162583Aloka Lisendo 880Hitachi, Ltd.201602
+10K163020Xperius Ultrasound SystemPhilips Health Care201611
+10K161960bk2300Bk Medical Aps20165—
+10K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+10K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+10K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+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—
+10K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+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—
+10K131527Logiq S8GE Healthcare2013219—
+10K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+10K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+10K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+10K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+10K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+10K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+10K120741Voluson S6, Voluson S8GE Healthcare2012295—
+10K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+11K260192DIANAROPCA ApS20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+11K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+11K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+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—
+11K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+11K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+11K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+11K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+11K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+11K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+11K242359Strain AI (SAI001)Exo, Inc.20240—
+11K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+11K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+11K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+11K232501AI Platform (AIP001)Exo, Inc.20231—
+11K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+11K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+11K230209Sonix HealthOntact Health Co., Ltd.20233—
+11K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+11K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—