510(k) Report

Devices descending from K961459

1,077 later devices reach Level 10 Hdi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+6K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+6K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+6K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+6K160524FibroScan 530 CompactEchosens201641—
+6K160182LOGIQ S7 ExpertGE Healthcare2016361
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+6K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+6K152195Logiq S8GE Healthcare201557—
+6K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+6K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+6K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+6K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+6K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+6K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+6K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+6K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+6K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+6K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+6K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+6K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+6K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+6K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+6K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+6K140677MylabssognoEsaote, S.p.A.20140—
+6K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+6K132861Ugeo H60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+6K131527Logiq S8GE Healthcare2013219—
+6K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+6K130803Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013106—
+6K124053Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20131—
+6K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+6K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+6K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+6K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+6K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+6K121384MylabsognoEsaote, S.p.A.201211
+6K120741Voluson S6, Voluson S8GE Healthcare2012295—
+6K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+6K110688MylabgoldEsaote2011251
+6K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+6K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+6K083882MylabfiveEsaote Europe B.V.200926—
+6K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+6K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+6K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+6K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K253452Accuro 3SRivanna Medical, Inc.20260—
+7K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+7K254021Accuro XVRivanna Medical, Inc.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+7K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+7K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+7K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+7K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+7K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K231764Ultrasound System 1300Bk Medical Aps202301
+7K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+7K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+7K222441Ultrasound System 2300Bk Medical Aps20221—
+7K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+7K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+7K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+7K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+7K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—