510(k) Report

Devices descending from K083149

330 later devices reach Arterial Health Package (Ahp) Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+6K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+6K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+6K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+6K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+6K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+6K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+6K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+6K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+6K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+6K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+6K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+6K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+6K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+6K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+6K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+6K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+6K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+6K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+6K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+6K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+6K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+7K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+7K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+7K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+7K212012Follicle ClarityCycle Clarity20221—
+7K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+7K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+7K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+7K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+7K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K2013523D Auto LAAPhilips Health Care20200—
+7K200356Medo AriaMedo.Ai20203—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+7K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+7K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+7K163690DC-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—
+7K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+7K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+7K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K252332FolliscanMim Fertility20260—
+8K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+8K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+8K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+8K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+8K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+8K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+8K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K200603AAA ModelPhilips Ultrasound, Inc.20200—
+8K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K181637DC-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—
+8K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+8K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—