510(k) Report

Devices descending from K992580

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+9K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+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—
+9K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220956Libby Echo:PrioDyad Medical, Inc.20221—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K212012Follicle ClarityCycle Clarity20221—
+9K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+9K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+9K201768Voluson E10GE Healthcare20204—
+9K2013523D Auto LAAPhilips Health Care20200—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+9K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+9K200356Medo AriaMedo.Ai20203—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K193518KosmosEchoNous, Inc.20201—
+9K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+9K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+9K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+9K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+9K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+9K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+9K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+9K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+9K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+9K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+9K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+9K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+9K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+9K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+9K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+9K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+9K171594AccuroRivanna Medical, LLC20173—
+9K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+9K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+9K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+9K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+9K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+9K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+9K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+9K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+9K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+9K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+9K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+9K161960bk2300Bk Medical Aps20165—
+9K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+9K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+9K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+9K1619555D ViewerSamsung Medison Co., Ltd.20163—
+9K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+9K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+9K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+9K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+9K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+9K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+9K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+9K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+9K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+9K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+9K150239FibroScanEchosens201525—
+9K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+9K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+9K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+9K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+9K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+9K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+9K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+9K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—