510(k) Report

Devices descending from K021497

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+8K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+8K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+8K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+8K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+8K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+8K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+8K150239FibroScanEchosens201525—
+8K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+8K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+8K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+8K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+8K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+8K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+8K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+8K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+8K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+8K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+8K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+8K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+8K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+8K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+8K142077MylabgammaEsaote, S.p.A.201453
+8K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+8K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+8K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+8K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+8K140808Q-StationPhilips Ultrasound, Inc.201402
+8K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+8K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+8K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+8K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+8K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+8K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+8K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+8K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+8K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+8K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+8K123806FibroscanEchosens201355—
+8K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+8K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+8K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+8K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+8K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+8K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+8K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+8K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+8K111582Logiq S8GE Healthcare20113673
+8K110943Logiq E9GE Healthcare20114722
+8K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+8K103649Voluson S6, Voluson S8GE Healthcare2011296—
+8K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+8K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+8K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+9K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+9K252332FolliscanMim Fertility20260—
+9K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+9K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+9K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—