510(k) Report

Devices descending from K033400

637 later devices reach Seno Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+12K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+12K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+13K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+13K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+13K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+13K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+13K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+13K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+13K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+13K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+13K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+14K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+14K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+14K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+14K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+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—
+14K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+14K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+15K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+15K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+15K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+16K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+16K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+17K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—