510(k) Report

Devices descending from K042055

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+7K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+7K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+7K150239FibroScanEchosens201525—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+7K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+7K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+7K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+7K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+7K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+7K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+7K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+7K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+7K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+7K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+7K142077MylabgammaEsaote, S.p.A.201453
+7K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+7K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+7K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+7K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+7K140808Q-StationPhilips Ultrasound, Inc.201402
+7K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+7K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+7K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+7K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+7K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+7K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+7K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+7K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+7K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+7K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+7K123806FibroscanEchosens201355—
+7K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+7K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+7K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+7K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+7K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+7K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+7K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K111582Logiq S8GE Healthcare20113673
+7K110943Logiq E9GE Healthcare20114722
+7K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+7K103649Voluson S6, Voluson S8GE Healthcare2011296—
+7K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+7K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+7K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K253452Accuro 3SRivanna Medical, Inc.20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K254021Accuro XVRivanna Medical, Inc.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+8K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+8K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+8K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212100KosmosEchoNous, Inc.202101
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—