510(k) Report

Devices descending from K970049

1,108 later devices reach BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K220956Libby Echo:PrioDyad Medical, Inc.20221—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K212012Follicle ClarityCycle Clarity20221—
+10K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+10K201768Voluson E10GE Healthcare20204—
+10K201693DC-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—
+10K2013523D Auto LAAPhilips Health Care20200—
+10K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+10K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+10K200356Medo AriaMedo.Ai20203—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K193518KosmosEchoNous, Inc.20201—
+10K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+10K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+10K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+10K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+10K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+10K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+10K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+10K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+10K171594AccuroRivanna Medical, LLC20173—
+10K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+10K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+10K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+10K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+10K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+10K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+10K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+10K161960bk2300Bk Medical Aps20165—
+10K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+10K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+10K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+10K1619555D ViewerSamsung Medison Co., Ltd.20163—
+10K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+10K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+10K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+10K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+10K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+10K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+10K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+10K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+10K150239FibroScanEchosens201525—
+10K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+10K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+10K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+10K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+10K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+10K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+10K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+10K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+10K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+10K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+10K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+10K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+10K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+10K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+10K140808Q-StationPhilips Ultrasound, Inc.201402
+10K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+10K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+10K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+10K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+10K123806FibroscanEchosens201355—
+10K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+10K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+10K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+10K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+10K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+10K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+10K111582Logiq S8GE Healthcare20113673
+10K110943Logiq E9GE Healthcare20114722
+10K103649Voluson S6, Voluson S8GE Healthcare2011296—
+10K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+10K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+10K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+11K252332FolliscanMim Fertility20260—