510(k) Report

Devices descending from K935009

1,062 later devices reach Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+6K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K170338A-ViewStroke2prevent B.V.20170—
+6K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+6K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+6K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+6K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+6K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+6K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+6K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+6K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+6K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+6K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+6K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+6K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+6K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+6K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+6K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+6K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+6K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+6K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+6K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+6K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+6K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+6K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+6K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+6K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+6K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+6K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+6K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+7K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.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—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+7K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+7K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+7K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+7K171594AccuroRivanna Medical, LLC20173—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+7K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+7K170069AmCAD-UVAmcad Biomed Corporation20170—
+7K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+7K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+7K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+7K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+7K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+7K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+7K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+7K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+7K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+7K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+7K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+7K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+7K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+7K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+7K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+7K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+7K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+7K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—