510(k) Report

Devices descending from K010950

994 later devices reach Cypress System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+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
+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—
+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—
+10K262390BoneXpertVisiana20260—
+10K251417ReVISION 2Argus Cognitive, Inc.20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K250914MediAI-BACrescom Co., Ltd.20250—
+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—
+10K250670EchoConfidence (USA)Mycardium AI Limited20250—
+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—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+10K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+10K241430EchoMeasureIcardio.Ai20240—
+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—
+10K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+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—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K2301796440 MyLabX90Esaote, S.p.A.202341
+10K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+10K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+10K222406Clarius AIClarius Mobile Health Corp.20233—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+10K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+10K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+10K211527Exo IrisExo Imaging, Inc.20211—
+10K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+10K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+10K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—