510(k) Report

Devices descending from K974698

8 later devices reach Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.20037—
+2K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+2K06030712 RL AlgorithmGe Medical Systems Information Technologies20065—
+2K033305Infinity Multiview Infinity Telemetry SystemDraeger Medical Systems, Inc.20030—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—