510(k) Report

Devices descending from K963807

242 later devices reach Tomtec Echo-Scan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+14K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+14K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+14K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+14K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+14K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+14K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+14K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+14K160524FibroScan 530 CompactEchosens201641—
+15K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+15K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+15K201597Liver Incytes, Model 1005Sonic Incytes20204—
+15K200655FibroScan® 630Echosens20200—
+15K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+15K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+15K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+15K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+15K172142FibroScan 430 Mini+Echosens20170—
+15K170445Logiq S8GE Healthcare2017191
+16K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+16K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+16K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+16K223287VelacurSonic Incytes20233—
+16K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+16K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+17K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+17K232459VelacurSonic Incytes20232—
+17K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+17K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+18K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+18K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+18K233977VelacurSonic Incytes20241—
+18K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+18K213102ES1 SystemE-Scopics20223—
+18K212035FibroScan 230Echosens20215—
+19K260748ES-SeriesE-Scopics20260—
+19K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+19K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+19K232336ES Series V2E-Scopics20232—
+20K260589ES-SeriesE-Scopics20260—
+20K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+20K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—