510(k) Report

Devices descending from K040227

908 later devices reach Qlab Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+6K181574UscanEchoNous, Inc.20180—
+6K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+6K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+6K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+6K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K173569Ultrasound System 1300Bk Medical Aps20181—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+6K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+6K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+6K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+6K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+6K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+6K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+6K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+6K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+6K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K161019Uroview FDPausch Medical GmbH201621
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+6K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+6K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+6K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+6K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+6K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+6K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+6K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+6K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+6K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+6K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+6K152195Logiq S8GE Healthcare201557—
+6K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+6K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K150949FibroScanEchosens201542—
+6K150663Diagnostic X-ray SystemOsko, Inc.20150—
+6K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+6K143281Ultimax-iToshibamedical Systems Corporation20150—
+6K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+6K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+6K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+6K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+6K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+6K133278Discovery Igs 740GE Medical Systems SCS201445
+6K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+6K132558Sync-RX SystemVolcano Corporation201331
+6K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+6K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+6K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+6K122768GenesisDornier Medtech America, Inc.20134—
+6K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+6K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+6K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+6K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+6K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+6K101042BladeviewAccogent, LLC20100—
+6K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+7K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+7K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+7K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+7K252332FolliscanMim Fertility20260—
+7K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+7K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K250955XC11 ICE System, USAYorlabs, Inc.20250—
+7K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+7K243884TavipilotCaranx Medical20250—
+7K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+7K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+7K233230See Factor CT3™Epica International, Inc.20240—
+7K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+7K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+7K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+7K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+7K231764Ultrasound System 1300Bk Medical Aps202301