510(k) Report

Devices descending from K935009

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K223830Ultrasound System 2300Bk Medical Aps202306
+14K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+14K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+14K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+14K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+14K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+14K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+14K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+14K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+14K213275EchoGo Core (2.0)Ultromics Limited20211—
+14K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+14K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+14K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+14K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+14K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+14K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+14K202422Arietta 65Hitachi Healthcare Americas20200—
+14K201768Voluson E10GE Healthcare20204—
+14K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+14K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+14K200138Versana PremierGe Medical Systems Ultrasound And20202—
+14K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+14K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+14K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+14K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+14K191233Arietta 750Hitachi Healthcare Americas201901
+14K190248Arietta 50Hitachi Healthcare Americas20191—
+14K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+14K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+14K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+14K171164U-Lite EXPSonoscanner20172—
+14K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+14K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+14K160162Voluson P6, Voluson P8GE Healthcare201613—
+14K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+14K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+14K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+14K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+14K133277XARIO 100Toshibamedical Systems Corporation20142—
+15K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+15K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+15K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+15K260589ES-SeriesE-Scopics20260—
+15K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+15K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+15K252007BlineSlideDeep Breathe, Inc.20250—
+15K251456BrightHeart View ClassifierBrightheart20250—
+15K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+15K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+15K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+15K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+15K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+15K234141AISAP Cardio V1.0Aisap20240—
+15K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+15K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+15K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+15K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+15K232459VelacurSonic Incytes20232—
+15K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+15K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+15K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+15K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+15K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+15K220851VenueGE Medical Systems20223—
+15K220848Venue FitGE Medical Systems202241
+15K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+15K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+15K220295Arietta 50Fujifilm Healthcare Corporation20220—
+15K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+15K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+15K211488Logiq E10GE Healthcare202111—
+15K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+15K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+15K201988T-LiteSonoscanner20201—
+15K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+15K181783Logiq P9; Logiq P7GE Healthcare2018171
+15K180535Voluson P6 and Voluson P8GE Healthcare2018121
+15K172256SoftVueDelphinus Medical Technologies20180—
+15K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+15K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+15K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+15K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+16K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+16K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+16K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+16K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+16K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+16K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+16K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+16K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+16K233977VelacurSonic Incytes20241—
+16K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+16K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+16K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421