510(k) Report

Devices descending from K003931

1,004 later devices reach Vivid 7 with Sonopac, Model FB0008XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K162583Aloka Lisendo 880Hitachi, Ltd.201602
+9K163020Xperius Ultrasound SystemPhilips Health Care201611
+9K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+9K162549Lumify Ultrasound SystemPhilips Health Care2016436
+9K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+9K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+9K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+9K160524FibroScan 530 CompactEchosens201641—
+9K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+9K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+9K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+10K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+10K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+10K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+10K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K2503303mensio WorkstationPie Medical Imaging BV202501
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+10K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+10K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+10K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+10K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+10K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+10K234141AISAP Cardio V1.0Aisap20240—
+10K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K233734Interson USB Ultrasound SystemInterson Corporation20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K230365Sonio DetectSonio20237—
+10K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+10K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+10K223830Ultrasound System 2300Bk Medical Aps202306
+10K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+10K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+10K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+10K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+10K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K212012Follicle ClarityCycle Clarity20221—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+10K2013523D Auto LAAPhilips Health Care20200—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+10K200356Medo AriaMedo.Ai20203—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+10K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+10K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+10K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+10K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+10K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+10K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+10K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+10K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+10K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+10K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+11K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+11K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+11K252332FolliscanMim Fertility20260—
+11K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+11K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+11K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+11K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+11K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242594DeepechoDeepecho20250—