510(k) Report

Devices descending from K002807

1,072 later devices reach 3D Organ Assessment W/ Magnetic Position Sensing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K170521Trinity/3D Prostate SuiteKoelis20170—
+12K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+12K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+12K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+12K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+12K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+12K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+12K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+12K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+12K143601U-LiteSonoscanner Sarl20153—
+12K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+12K141768Logiq V5/Logiq V3GE Healthcare201457—
+12K141675Voluson P6, Voluson P8GE Healthcare201414—
+12K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+12K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+13K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+13K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+13K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+13K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+13K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+13K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+13K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+13K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+13K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+13K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+13K232336ES Series V2E-Scopics20232—
+13K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+13K223287VelacurSonic Incytes20233—
+13K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+13K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+13K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+13K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+13K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+13K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+13K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+13K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+13K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+13K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+13K211527Exo IrisExo Imaging, Inc.20211—
+13K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+13K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+13K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+13K202422Arietta 65Hitachi Healthcare Americas20200—
+13K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+13K200138Versana PremierGe Medical Systems Ultrasound And20202—
+13K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+13K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+13K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+13K191233Arietta 750Hitachi Healthcare Americas201901
+13K190248Arietta 50Hitachi Healthcare Americas20191—
+13K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+13K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+13K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+13K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+13K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+13K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+13K171164U-Lite EXPSonoscanner20172—
+13K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+13K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+13K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+13K160162Voluson P6, Voluson P8GE Healthcare201613—
+13K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+14K260589ES-SeriesE-Scopics20260—
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+14K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+14K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+14K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+14K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+14K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+14K232459VelacurSonic Incytes20232—
+14K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+14K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+14K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+14K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+14K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+14K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+14K220851VenueGE Medical Systems20223—
+14K220848Venue FitGE Medical Systems202241
+14K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+14K220295Arietta 50Fujifilm Healthcare Corporation20220—