510(k) Report

Devices descending from K970049

1,108 later devices reach BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+13K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+13K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+13K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+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—
+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—
+13K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+13K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+13K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+13K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+13K201597Liver Incytes, Model 1005Sonic Incytes20204—
+13K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+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
+13K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+13K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+13K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+13K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+13K172256SoftVueDelphinus Medical Technologies20180—
+13K173555Logiq E10GE Healthcare2017382
+13K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+13K172142FibroScan 430 Mini+Echosens20170—
+13K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+13K170521Trinity/3D Prostate SuiteKoelis20170—
+13K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+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—
+13K143601U-LiteSonoscanner Sarl20153—
+13K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+13K141768Logiq V5/Logiq V3GE Healthcare201457—
+13K141675Voluson P6, Voluson P8GE Healthcare201414—
+13K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+13K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+14K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+14K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+14K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+14K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+14K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+14K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+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—
+14K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+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—
+14K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+14K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+14K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+14K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+14K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+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—
+14K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+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—
+14K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+14K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+14K211527Exo IrisExo Imaging, Inc.20211—