510(k) Report

Devices descending from K010329

717 later devices reach LOGIQ 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+14K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+14K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+14K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+14K213102ES1 SystemE-Scopics20223—
+14K212035FibroScan 230Echosens20215—
+15K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+15K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+15K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+15K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+15K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+15K232336ES Series V2E-Scopics20232—
+16K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+16K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+16K260589ES-SeriesE-Scopics20260—
+16K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+16K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—