510(k) Report

Devices descending from K071234

356 later devices reach Acunav Diagnostic Ultrasound Catheter 8F and 10F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250955XC11 ICE System, USAYorlabs, Inc.20250—
+1K201775NuVision ICE CatheterNuvera Medical, Inc.20212—
+1K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+1K170263AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc.20176—
+1K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC20161—
+1K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+1K133853Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company201414—
+1K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+1K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+1K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+1K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.20099—
+2K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+2K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…Surgical Instrument Service and Savings, Inc.20250—
+2K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…Surgical Instrument Service and Savings, Inc.20240Class I
+2K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20240—
+2K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.20230Class I
+2K233270AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc.20231—
+2K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions20230—
+2K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—
+2K222217ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical20225—
+2K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company20224—
+2K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC20200—
+2K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation20201—
+2K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc.20190—
+2K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions201911
+2K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC20181—
+2K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+2K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+2K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+2K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+2K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+2K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+2K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+2K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+2K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+2K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+2K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+2K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+2K101138Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc.20101—
+3K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc.20260—
+3K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+3K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+3K251231ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical20250—
+3K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…Philips Image Guided Therapy Corporation20250—
+3K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.20241—
+3K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20234—
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+3K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+3K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+3K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+3K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+3K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+3K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+3K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+3K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+3K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+3K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+3K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+3K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+3K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K260748ES-SeriesE-Scopics20260—
+4K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+4K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+4K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+4K231588ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20233—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+4K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+4K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+4K163690DC-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—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+4K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+4K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—