510(k) Report

Devices descending from K930768

221 later devices reach Orion Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+14K242359Strain AI (SAI001)Exo, Inc.20240—
+14K242223SuperSonic HepaVuSupersonic Imagine20240—
+14K232501AI Platform (AIP001)Exo, Inc.20231—
+14K231764Ultrasound System 1300Bk Medical Aps202301
+14K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+14K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+14K222441Ultrasound System 2300Bk Medical Aps20221—
+14K212376Caas QardiaPie Medical Imaging BV20220—
+14K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+14K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+14K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+14K213275EchoGo Core (2.0)Ultromics Limited20211—
+14K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+14K200603AAA ModelPhilips Ultrasound, Inc.20200—
+14K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+14K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+14K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+14K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+14K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+14K161999AixplorerSupersonic Imagine201620—
+14K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+14K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+14K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+14K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+14K133277XARIO 100Toshibamedical Systems Corporation20142—
+15K2503303mensio WorkstationPie Medical Imaging BV202501
+15K252007BlineSlideDeep Breathe, Inc.20250—
+15K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+15K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+15K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+15K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+15K234141AISAP Cardio V1.0Aisap20240—
+15K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+15K230209Sonix HealthOntact Health Co., Ltd.20233—
+15K223830Ultrasound System 2300Bk Medical Aps202306
+15K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+15K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+15K200708Vivid iqGe Medical Systems Ultrasound And20203—
+15K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+15K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+15K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+15K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+15K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+15K172256SoftVueDelphinus Medical Technologies20180—
+15K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+15K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+15K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+15K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+15K150949FibroScanEchosens201542—
+15K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+16K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+16K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+16K243684BrightHeart View ClassifierBrightheart20251—
+16K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K240645Sonix HealthOntact Health Co., Ltd.20240—
+16K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+16K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+16K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+16K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+16K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+16K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+16K201768Voluson E10GE Healthcare20204—
+16K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+16K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+16K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+16K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+16K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+16K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+16K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+16K160524FibroScan 530 CompactEchosens201641—
+17K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+17K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+17K251456BrightHeart View ClassifierBrightheart20250—
+17K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+17K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+17K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+17K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+17K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+17K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+17K201597Liver Incytes, Model 1005Sonic Incytes20204—
+17K200655FibroScan® 630Echosens20200—
+17K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+17K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+17K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+17K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+17K172142FibroScan 430 Mini+Echosens20170—
+17K170445Logiq S8GE Healthcare2017191
+18K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+18K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+18K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+18K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+18K223287VelacurSonic Incytes20233—
+18K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+18K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+18K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+18K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—