510(k) Report

Devices descending from K042540

882 later devices reach Philips IU22 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152195Logiq S8GE Healthcare201557—
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150949FibroScanEchosens201542—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+5K143281Ultimax-iToshibamedical Systems Corporation20150—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+5K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+5K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+5K132558Sync-RX SystemVolcano Corporation201331
+5K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K122768GenesisDornier Medtech America, Inc.20134—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+5K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+5K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+5K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+5K101042BladeviewAccogent, LLC20100—
+5K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+6K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+6K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+6K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+6K252332FolliscanMim Fertility20260—
+6K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+6K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+6K243884TavipilotCaranx Medical20250—
+6K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+6K233230See Factor CT3™Epica International, Inc.20240—
+6K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+6K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+6K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+6K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+6K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+6K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+6K231764Ultrasound System 1300Bk Medical Aps202301
+6K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+6K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+6K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+6K223550DMXDel Medical, Inc.20230—
+6K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+6K222441Ultrasound System 2300Bk Medical Aps20221—
+6K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+6K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+6K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+6K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+6K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+6K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+6K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+6K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+6K213479D²RS and D²RS 9090Stephanix20211—
+6K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+6K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+6K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+6K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+6K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+6K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+6K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+6K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+6K200655FibroScan® 630Echosens20200—