510(k) Report

Devices descending from K922470

121 later devices reach Ies, Image Enhancement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993802Sharpview Image Enhancement SystemContext Vision AB2000120—
+2K173605iQMRMedic Vision - Imaging Solutions, Ltd.20180—
+2K140139ClearviewhdClearview Diagnostics, Inc.20140—
+2K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc.20060—
+2K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+2K024028Sharp View Image Enhancement SystemContext Vision AB2003106—
+3K172768ZOOMZetta Medical Technologies, LLC201822—
+3K160852ZiaZetta Medical Technologies, LLC20164—
+3K100372Safect Model Ver 1.0Medic Vision Brain Technologies, Ltd.20101—
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K063391Sapheneia ClaritySapheneia Commercial Products AB20079—
+3K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.200564—
+4K212550Hura CTP v1.0Hura Imaging, Inc.20210—
+4K212470iRADClaritas Healthtech Pte, Ltd.20210—
+4K191688SubtleMRSubtle Medical, Inc.201920—
+4K183460ClariCT.AIClaripi, Inc.20193—
+4K182336SubtlePETSubtle Medical, Inc.20185—
+4K161625PixelShineAlgomedica20160—
+4K141870Breast Volume NavigatorMetritrack, LLC20142—
+4K140395Vitrea Image Denoising SoftwareVital Images, Inc.20140—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K082543Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc.20082—
+4K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc.200831
+4K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation200853—
+4K070477Orison Embrace SystemOrison Corporation20073—
+5K260190ArthurROPCA ApS20260—
+5K241121Micsi-RMTMicrostructure Imaging, Inc.20240—
+5K213620ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc.20220—
+5K213140Claritas iPETClaritas Healthtech Pte, Ltd.20212—
+5K202404BoneMRIMriguidance B.V.20215—
+5K210999SwiftMRAirs Medical, Inc.20216—
+5K211964SubtlePETSubtle Medical, Inc.20212—
+5K212074ClariCT.AIClaripi, Inc.20212—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K203182SubtleMRSubtle Medical, Inc.20216—
+5K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+5K161354MELODY, Remote Control System for Ultrasound ProbeAdecho Tech20171—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K123209SoftvueDelphinus Medical Technologies, Inc.201350—
+5K092954Cadstream Version 5Confirma, Inc.200983
+5K092067Abvs WorkplaceSiemens AG Medical Solutions20092—
+6K261305Micsi-PetMicrostructure Imaging, Inc.20260—
+6K254120SubtleHD-CT (1.x)Subtle Medical, Inc.20260—
+6K254013SubtleHD-PET (1.x)Subtle Medical, Inc.20260—
+6K244002AngioWaveNetAngiowave Imaging, Inc.20250—
+6K244016iPETcertum (v1.0)Claritas Healthtech Pte, Ltd.20250—
+6K241982DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies, Inc.20250—
+6K242334Ezra FlashEzra Ai, Inc.20250—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K223623SubtleMR (2.3.x)Subtle Medical, Inc.20233—
+6K230264Ezra FlashEzra Ai, Inc.20231—
+6K221762BoneMRI v1.4Mrlguidance B.V.20224—
+6K220416SwiftMRAirs Medical, Inc.20224—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K151075BR-ABVS Viewer 1.0Taihao Medical, Inc.20161—
+6K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K243250SubtleHD (1.x)Subtle Medical, Inc.20250—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K241681Overjet Image Enhancement AssistOverjet, Inc.20240—
+7K240290AiMIFY (1.x)Subtle Medical, Inc.20240—
+7K230854SwiftMRAirs Medical, Inc.20233—
+7K230197BoneMRI v1.6Mriguidance B.V.20233—
+7K180641Invenia ABUS ViewerGE Healthcare20180—
+7K172256SoftVueDelphinus Medical Technologies20180—
+7K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+7K150949FibroScanEchosens201542—
+8K253775SwiftMRAirs Medical, Inc.20261—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K233030BoneMRIMriguidance B.V.20242—
+8K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+8K160524FibroScan 530 CompactEchosens201641—
+9K260525NextMR SpineMRI2CT, Inc.20260—
+9K260584BoneMRIMriguidance B.V.20260—
+9K261349SwiftMRAirs Medical, Inc.20260—
+9K201597Liver Incytes, Model 1005Sonic Incytes20204—
+9K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+9K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+9K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+9K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+9K172142FibroScan 430 Mini+Echosens20170—
+9K170445Logiq S8GE Healthcare2017191
+10K223287VelacurSonic Incytes20233—
+10K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+10K200655FibroScan® 630Echosens20200—
+10K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+11K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+11K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+11K232459VelacurSonic Incytes20232—
+11K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+11K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+11K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+12K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—