510(k) Report

Devices descending from K982976

213 later devices reach Ultrasound Workstation, Uiws-300A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—