510(k) Report

Devices descending from K002470

1,238 later devices reach M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+7K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+7K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+7K161019Uroview FDPausch Medical GmbH201621
+7K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+7K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+7K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+7K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+7K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+7K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+7K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+7K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+7K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+7K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+7K152195Logiq S8GE Healthcare201557—
+7K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+7K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+7K150949FibroScanEchosens201542—
+7K150663Diagnostic X-ray SystemOsko, Inc.20150—
+7K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+7K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+7K143281Ultimax-iToshibamedical Systems Corporation20150—
+7K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+7K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+7K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+7K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+7K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+7K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+7K133278Discovery Igs 740GE Medical Systems SCS201445
+7K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+7K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+7K132558Sync-RX SystemVolcano Corporation201331
+7K131158CorviewMarrek, Inc.20130—
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K122768GenesisDornier Medtech America, Inc.20134—
+7K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+7K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+7K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+7K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+7K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+7K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+7K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+7K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+7K101042BladeviewAccogent, LLC20100—
+7K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+7K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+7K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+7K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+7K083421MR-Touch OptionGe Medical Systems, LLC20094—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+7K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+7K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006193—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+8K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+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—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K252105Ligence HeartLigence Uab20250—
+8K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+8K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+8K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+8K243884TavipilotCaranx Medical20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K241430EchoMeasureIcardio.Ai20240—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+8K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+8K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K233230See Factor CT3™Epica International, Inc.20240—
+8K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—