510(k) Report

Devices descending from K961459

1,077 later devices reach Level 10 Hdi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+12K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+12K241029SpineUs™ SystemVerdure Imaging20240—
+12K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+12K230365Sonio DetectSonio20237—
+12K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+12K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K222406Clarius AIClarius Mobile Health Corp.20233—
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+12K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+12K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+12K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+12K191171EchoGo CoreUltromics, Ltd.20193—
+12K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+12K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+13K251417ReVISION 2Argus Cognitive, Inc.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K260192DIANAROPCA ApS20260—
+13K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+13K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+13K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K250670EchoConfidence (USA)Mycardium AI Limited20250—
+13K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K242594DeepechoDeepecho20250—
+13K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+13K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+13K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+13K242359Strain AI (SAI001)Exo, Inc.20240—
+13K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+13K233955Clarius OB AIClarius Mobile Health Corp.20240—
+13K240406Sonio DetectSonio20244—
+13K232501AI Platform (AIP001)Exo, Inc.20231—
+13K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+13K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+13K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+13K212376Caas QardiaPie Medical Imaging BV20220—
+13K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+13K213275EchoGo Core (2.0)Ultromics Limited20211—
+13K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+13K200603AAA ModelPhilips Ultrasound, Inc.20200—
+13K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+14K252433Sonio Detect (v3)Sonio20260—
+14K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+14K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+14K250959BioticsAIBioticsai, Inc.20250—
+14K2503303mensio WorkstationPie Medical Imaging BV202501
+14K252007BlineSlideDeep Breathe, Inc.20250—
+14K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+14K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+14K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+14K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+14K241380Fetoly-HeartDiagnoly20241—
+14K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+14K234141AISAP Cardio V1.0Aisap20240—
+14K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+14K230209Sonix HealthOntact Health Co., Ltd.20233—
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+15K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+15K251368FetolyDiagnoly20250—
+15K243684BrightHeart View ClassifierBrightheart20251—
+15K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+15K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+15K240645Sonix HealthOntact Health Co., Ltd.20240—
+16K251456BrightHeart View ClassifierBrightheart20250—