510(k) Report

Devices descending from K930768

221 later devices reach Orion Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+19K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+19K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+19K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+19K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+19K232459VelacurSonic Incytes20232—
+19K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+19K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+20K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+20K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+20K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+20K233977VelacurSonic Incytes20241—
+20K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+20K213102ES1 SystemE-Scopics20223—
+20K212035FibroScan 230Echosens20215—
+21K260748ES-SeriesE-Scopics20260—
+21K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+21K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+21K232336ES Series V2E-Scopics20232—
+22K260589ES-SeriesE-Scopics20260—
+22K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+22K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—