510(k) Report

Devices descending from K934139

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+8K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+8K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+8K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+8K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+8K152829Visions PV.014P RX Digital IVUS CatheterVolcano Corporation201541
+8K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+8K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+8K152195Logiq S8GE Healthcare201557—
+8K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+8K152250SpeqRTSignostics Limited20150—
+8K150949FibroScanEchosens201542—
+8K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+8K150663Diagnostic X-ray SystemOsko, Inc.20150—
+8K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+8K143281Ultimax-iToshibamedical Systems Corporation20150—
+8K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+8K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+8K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+8K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+8K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+8K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+8K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+8K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+8K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+8K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+8K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+8K133278Discovery Igs 740GE Medical Systems SCS201445
+8K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+8K132558Sync-RX SystemVolcano Corporation201331
+8K131158CorviewMarrek, Inc.20130—
+8K130779Lvivo EF SystemDiacardio, Ltd.201324—
+8K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+8K122768GenesisDornier Medtech America, Inc.20134—
+8K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+8K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+8K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+8K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+8K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+8K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+8K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+8K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+8K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+8K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+8K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+8K101042BladeviewAccogent, LLC20100—
+8K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+8K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+8K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+8K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+8K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+8K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+8K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+8K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+8K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006193—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+9K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+9K252332FolliscanMim Fertility20260—
+9K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K2503303mensio WorkstationPie Medical Imaging BV202501
+9K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+9K252007BlineSlideDeep Breathe, Inc.20250—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+9K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+9K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+9K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+9K243884TavipilotCaranx Medical20250—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+9K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+9K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K233230See Factor CT3™Epica International, Inc.20240—
+9K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+9K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+9K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+9K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+9K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+9K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—