510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+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—
+9K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+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—
+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—
+9K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+9K163119NaviSuite SSI EditionMedcom GmbH20171—
+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
+9K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+9K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+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—
+9K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+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—
+9K150239FibroScanEchosens201525—
+9K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+9K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+9K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+9K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+9K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+9K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+9K142077MylabgammaEsaote, S.p.A.201453
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+9K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+9K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+9K140808Q-StationPhilips Ultrasound, Inc.201402
+9K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+9K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+9K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+9K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+9K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+9K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+9K131158CorviewMarrek, Inc.20130—
+9K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+9K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+9K123806FibroscanEchosens201355—
+9K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+9K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+9K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+9K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+9K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+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—
+10K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper 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—
+10K250670EchoConfidence (USA)Mycardium AI Limited20250—
+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—
+10K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+10K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+10K241430EchoMeasureIcardio.Ai20240—
+10K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+10K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+10K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+10K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+10K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K2301796440 MyLabX90Esaote, S.p.A.202341
+10K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+10K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+10K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—