510(k) Report

Devices descending from K894632

405 later devices reach Model SSH-140A Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K133277XARIO 100Toshibamedical Systems Corporation20142—
+15K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+15K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+15K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+15K2503303mensio WorkstationPie Medical Imaging BV202501
+15K252007BlineSlideDeep Breathe, Inc.20250—
+15K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+15K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+15K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+15K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+15K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+15K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+15K234141AISAP Cardio V1.0Aisap20240—
+15K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+15K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+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—
+15K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+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
+16K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+16K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+16K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+16K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+16K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+16K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+16K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+16K243684BrightHeart View ClassifierBrightheart20251—
+16K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+16K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+16K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+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—
+16K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+16K201768Voluson E10GE Healthcare20204—
+16K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+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—
+17K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+17K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+17K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+17K251456BrightHeart View ClassifierBrightheart20250—
+17K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+17K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+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
+18K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+18K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+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—
+18K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+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—
+19K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+19K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+19K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+19K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+19K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+19K232459VelacurSonic Incytes20232—
+19K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+19K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+20K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+20K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+20K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+20K233977VelacurSonic Incytes20241—
+20K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+20K213102ES1 SystemE-Scopics20223—
+20K212035FibroScan 230Echosens20215—
+21K260748ES-SeriesE-Scopics20260—
+21K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—