510(k) Report

Devices descending from K891689

901 later devices reach Mipron/Umipron through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+9K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+9K161999AixplorerSupersonic Imagine201620—
+9K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+9K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+9K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+9K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+9K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+9K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+9K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+9K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+9K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+9K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+9K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+9K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+9K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+9K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+9K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+9K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+9K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+9K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+9K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+9K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+9K140677MylabssognoEsaote, S.p.A.20140—
+9K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+9K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+9K132274AixplorerSupersonic Imagine2013312—
+9K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+9K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+9K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+9K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+9K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+9K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+9K111142Echosoft (TM)Echometrix, LLC20120—
+9K112255AixplorerSupersonic Imagine2012525—
+9K121384MylabsognoEsaote, S.p.A.201211
+9K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+9K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+9K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+9K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+9K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+9K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+9K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+9K110688MylabgoldEsaote2011251
+9K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+9K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+9K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+9K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+9K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+9K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+9K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+9K083421MR-Touch OptionGe Medical Systems, LLC20094—
+10K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+10K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+10K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+10K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+10K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+10K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+10K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+10K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+10K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+10K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+10K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+10K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K212012Follicle ClarityCycle Clarity20221—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+10K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143