510(k) Report

Devices descending from K935009

1,062 later devices reach Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+11K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+11K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+11K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+11K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+11K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+11K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+11K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+11K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.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—
+11K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+11K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+11K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+11K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+11K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+11K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+11K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+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—
+11K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+11K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+11K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+11K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+11K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+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—
+11K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+11K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+11K170841BiopSee, Mobile USMedcom GmbH20170—
+11K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K163505Arietta PrecisionHitachi, Ltd.20170—
+11K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+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
+11K161960bk2300Bk Medical Aps20165—
+11K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+11K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+11K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+11K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+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—
+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—
+11K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+11K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+11K131527Logiq S8GE Healthcare2013219—
+11K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+11K120282CardnavPaieon, Inc.20120—
+11K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+11K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+11K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+11K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+11K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+12K262390BoneXpertVisiana20260—
+12K251417ReVISION 2Argus Cognitive, Inc.20260—
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K250914MediAI-BACrescom Co., Ltd.20250—
+12K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+12K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+12K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+12K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+12K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+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
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+12K230778EndoCorePraxis Medical, LLC20230—
+12K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+12K223422Emory Cardiac Toolbox 4.3Syntermed20230—