510(k) Report

Devices descending from K993802

120 later devices reach Sharpview Image Enhancement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173605iQMRMedic Vision - Imaging Solutions, Ltd.20180—
+1K140139ClearviewhdClearview Diagnostics, Inc.20140—
+1K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc.20060—
+1K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+1K024028Sharp View Image Enhancement SystemContext Vision AB2003106—
+2K172768ZOOMZetta Medical Technologies, LLC201822—
+2K160852ZiaZetta Medical Technologies, LLC20164—
+2K100372Safect Model Ver 1.0Medic Vision Brain Technologies, Ltd.20101—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K063391Sapheneia ClaritySapheneia Commercial Products AB20079—
+2K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.200564—
+3K212550Hura CTP v1.0Hura Imaging, Inc.20210—
+3K212470iRADClaritas Healthtech Pte, Ltd.20210—
+3K191688SubtleMRSubtle Medical, Inc.201920—
+3K183460ClariCT.AIClaripi, Inc.20193—
+3K182336SubtlePETSubtle Medical, Inc.20185—
+3K161625PixelShineAlgomedica20160—
+3K141870Breast Volume NavigatorMetritrack, LLC20142—
+3K140395Vitrea Image Denoising SoftwareVital Images, Inc.20140—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K082543Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc.20082—
+3K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc.200831
+3K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation200853—
+3K070477Orison Embrace SystemOrison Corporation20073—
+4K260190ArthurROPCA ApS20260—
+4K241121Micsi-RMTMicrostructure Imaging, Inc.20240—
+4K213620ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc.20220—
+4K213140Claritas iPETClaritas Healthtech Pte, Ltd.20212—
+4K202404BoneMRIMriguidance B.V.20215—
+4K210999SwiftMRAirs Medical, Inc.20216—
+4K211964SubtlePETSubtle Medical, Inc.20212—
+4K212074ClariCT.AIClaripi, Inc.20212—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K203182SubtleMRSubtle Medical, Inc.20216—
+4K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+4K161354MELODY, Remote Control System for Ultrasound ProbeAdecho Tech20171—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K123209SoftvueDelphinus Medical Technologies, Inc.201350—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K092067Abvs WorkplaceSiemens AG Medical Solutions20092—
+5K261305Micsi-PetMicrostructure Imaging, Inc.20260—
+5K254120SubtleHD-CT (1.x)Subtle Medical, Inc.20260—
+5K254013SubtleHD-PET (1.x)Subtle Medical, Inc.20260—
+5K244002AngioWaveNetAngiowave Imaging, Inc.20250—
+5K244016iPETcertum (v1.0)Claritas Healthtech Pte, Ltd.20250—
+5K241982DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies, Inc.20250—
+5K242334Ezra FlashEzra Ai, Inc.20250—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K223623SubtleMR (2.3.x)Subtle Medical, Inc.20233—
+5K230264Ezra FlashEzra Ai, Inc.20231—
+5K221762BoneMRI v1.4Mrlguidance B.V.20224—
+5K220416SwiftMRAirs Medical, Inc.20224—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K151075BR-ABVS Viewer 1.0Taihao Medical, Inc.20161—
+5K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K243250SubtleHD (1.x)Subtle Medical, Inc.20250—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K241681Overjet Image Enhancement AssistOverjet, Inc.20240—
+6K240290AiMIFY (1.x)Subtle Medical, Inc.20240—
+6K230854SwiftMRAirs Medical, Inc.20233—
+6K230197BoneMRI v1.6Mriguidance B.V.20233—
+6K180641Invenia ABUS ViewerGE Healthcare20180—
+6K172256SoftVueDelphinus Medical Technologies20180—
+6K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+6K150949FibroScanEchosens201542—
+7K253775SwiftMRAirs Medical, Inc.20261—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K233030BoneMRIMriguidance B.V.20242—
+7K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+7K160524FibroScan 530 CompactEchosens201641—
+8K260525NextMR SpineMRI2CT, Inc.20260—
+8K260584BoneMRIMriguidance B.V.20260—
+8K261349SwiftMRAirs Medical, Inc.20260—
+8K201597Liver Incytes, Model 1005Sonic Incytes20204—
+8K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+8K172142FibroScan 430 Mini+Echosens20170—
+8K170445Logiq S8GE Healthcare2017191
+9K223287VelacurSonic Incytes20233—
+9K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+9K200655FibroScan® 630Echosens20200—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+10K232459VelacurSonic Incytes20232—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+10K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+11K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+11K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—