510(k) Report

Devices descending from K992580

1,070 later devices reach Fetal Assessment Cap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+8K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+8K181574UscanEchoNous, Inc.20180—
+8K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+8K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K173810Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd.20180—
+8K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+8K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+8K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+8K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+8K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+8K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+8K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+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—
+8K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+8K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+8K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+8K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+8K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+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—
+8K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+8K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+8K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+8K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+8K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+8K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+8K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+8K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+8K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+8K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+8K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+8K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+8K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+8K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+8K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+8K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+8K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+8K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+8K132274AixplorerSupersonic Imagine2013312—
+8K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+8K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+8K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+8K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+8K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+8K111142Echosoft (TM)Echometrix, LLC20120—
+8K112255AixplorerSupersonic Imagine2012525—
+8K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+8K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+8K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+8K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+8K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+8K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+8K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+8K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+8K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+8K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+8K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+8K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+8K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+8K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+8K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+8K083421MR-Touch OptionGe Medical Systems, LLC20094—
+9K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+9K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+9K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+9K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—