510(k) Report

Devices descending from K992631

1,093 later devices reach Acunav Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+9K201768Voluson E10GE Healthcare20204—
+9K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+9K2013523D Auto LAAPhilips Health Care20200—
+9K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+9K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+9K200356Medo AriaMedo.Ai20203—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K193518KosmosEchoNous, Inc.20201—
+9K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+9K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+9K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+9K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+9K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+9K171594AccuroRivanna Medical, LLC20173—
+9K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+9K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+9K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+9K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+9K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+9K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+9K161960bk2300Bk Medical Aps20165—
+9K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+9K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+9K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+9K1619555D ViewerSamsung Medison Co., Ltd.20163—
+9K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+9K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+9K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+9K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+9K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+9K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+9K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+9K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+9K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+9K150239FibroScanEchosens201525—
+9K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+9K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+9K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+9K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+9K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+9K140808Q-StationPhilips Ultrasound, Inc.201402
+9K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+9K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+9K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+9K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+9K123806FibroscanEchosens201355—
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+9K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+9K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+9K111582Logiq S8GE Healthcare20113673
+9K110943Logiq E9GE Healthcare20114722
+9K103649Voluson S6, Voluson S8GE Healthcare2011296—
+9K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+9K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+9K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K252332FolliscanMim Fertility20260—
+10K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K252105Ligence HeartLigence Uab20250—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K243937Accuro 3SRivanna Medical, Inc.20252—
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—