510(k) Report

Devices descending from K934139

1,289 later devices reach Tomtec Echo-View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+7K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+7K150239FibroScanEchosens201525—
+7K143701Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Volcano Corporation201510—
+7K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+7K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+7K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+7K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+7K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+7K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+7K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+7K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+7K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+7K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+7K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+7K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+7K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+7K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+7K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+7K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+7K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+7K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+7K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+7K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+7K123806FibroscanEchosens201355—
+7K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+7K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+7K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+7K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+7K121513Multix FusionSiemens Medical Solution2012324
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K120697Eagle Eye Platinum ST CatheterVolcano Corporation201212—
+7K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+7K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+7K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011100—
+7K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+7K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+7K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+7K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+7K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+7K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc.20100—
+7K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+7K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+7K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+7K083597Sonowand InviteSonowand AS20093—
+7K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+7K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+7K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+7K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+7K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+7K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+7K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+7K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+7K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+7K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005194—
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K260192DIANAROPCA ApS20260—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K242359Strain AI (SAI001)Exo, Inc.20240—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232501AI Platform (AIP001)Exo, Inc.20231—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—