510(k) Report

Devices descending from K960613

914 later devices reach GE Advantage Windows Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+16K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+16K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+17K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—