510(k) Report

Devices descending from K935009

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+13K231764Ultrasound System 1300Bk Medical Aps202301
+13K230209Sonix HealthOntact Health Co., Ltd.20233—
+13K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+13K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+13K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+13K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+13K222406Clarius AIClarius Mobile Health Corp.20233—
+13K222441Ultrasound System 2300Bk Medical Aps20221—
+13K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+13K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+13K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+13K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+13K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+13K213102ES1 SystemE-Scopics20223—
+13K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+13K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+13K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+13K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+13K212035FibroScan 230Echosens20215—
+13K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+13K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+13K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+13K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+13K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+13K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+13K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+13K201597Liver Incytes, Model 1005Sonic Incytes20204—
+13K191171EchoGo CoreUltromics, Ltd.20193—
+13K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+13K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+13K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+13K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+13K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+13K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+13K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+13K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+13K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+13K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+13K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+13K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+13K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+13K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+13K173555Logiq E10GE Healthcare2017382
+13K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+13K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+13K172142FibroScan 430 Mini+Echosens20170—
+13K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+13K170521Trinity/3D Prostate SuiteKoelis20170—
+13K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+13K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+13K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+13K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+13K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+13K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+13K143601U-LiteSonoscanner Sarl20153—
+13K141768Logiq V5/Logiq V3GE Healthcare201457—
+13K141675Voluson P6, Voluson P8GE Healthcare201414—
+13K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+13K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+13K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+13K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+14K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+14K260192DIANAROPCA ApS20260—
+14K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+14K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+14K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+14K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+14K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+14K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+14K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+14K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K250670EchoConfidence (USA)Mycardium AI Limited20250—
+14K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+14K243684BrightHeart View ClassifierBrightheart20251—
+14K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+14K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+14K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+14K240645Sonix HealthOntact Health Co., Ltd.20240—
+14K242359Strain AI (SAI001)Exo, Inc.20240—
+14K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+14K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+14K242223SuperSonic HepaVuSupersonic Imagine20240—
+14K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+14K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+14K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+14K232501AI Platform (AIP001)Exo, Inc.20231—
+14K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+14K232336ES Series V2E-Scopics20232—
+14K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+14K223287VelacurSonic Incytes20233—