510(k) Report

Devices descending from K070792

202 later devices reach Qlab Quantification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+5K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+5K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+6K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+6K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+6K252332FolliscanMim Fertility20260—
+6K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+6K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+6K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+6K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+6K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+6K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+6K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+6K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+6K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+6K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+6K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+6K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+6K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+6K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+6K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+7K262390BoneXpertVisiana20260—
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K250914MediAI-BACrescom Co., Ltd.20250—
+7K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+7K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+7K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+7K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+7K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+7K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+7K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+7K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+7K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+7K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+8K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+8K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+8K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+8K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+8K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+8K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+8K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+8K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+9K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+9K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+9K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+9K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+9K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+10K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+10K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+10K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+10K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+11K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+11K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+11K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+11K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+11K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+12K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+12K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—