510(k) Report

Devices descending from K963315

405 later devices reach Vingmed Sound Color Flow Mapping System. System Five through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K211527Exo IrisExo Imaging, Inc.20211—
+12K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+12K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+12K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+12K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+12K172256SoftVueDelphinus Medical Technologies20180—
+12K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+12K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+12K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+12K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+12K150949FibroScanEchosens201542—
+12K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+13K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+13K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+13K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+13K243684BrightHeart View ClassifierBrightheart20251—
+13K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+13K240645Sonix HealthOntact Health Co., Ltd.20240—
+13K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+13K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+13K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+13K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+13K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+13K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+13K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+13K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+13K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+13K201768Voluson E10GE Healthcare20204—
+13K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+13K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+13K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+13K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+13K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+13K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+13K160524FibroScan 530 CompactEchosens201641—
+14K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+14K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+14K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+14K251456BrightHeart View ClassifierBrightheart20250—
+14K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+14K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+14K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+14K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+14K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+14K201597Liver Incytes, Model 1005Sonic Incytes20204—
+14K200655FibroScan® 630Echosens20200—
+14K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+14K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+14K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+14K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+14K172142FibroScan 430 Mini+Echosens20170—
+14K170445Logiq S8GE Healthcare2017191
+15K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+15K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+15K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+15K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+15K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+15K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+15K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+15K223287VelacurSonic Incytes20233—
+15K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+15K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+15K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+15K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+16K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+16K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+16K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+16K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+16K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+16K232459VelacurSonic Incytes20232—
+16K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+16K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+17K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+17K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+17K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+17K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+17K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+17K233977VelacurSonic Incytes20241—
+17K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+17K213102ES1 SystemE-Scopics20223—
+17K212035FibroScan 230Echosens20215—
+18K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+18K260748ES-SeriesE-Scopics20260—
+18K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—