510(k) Report

Devices descending from K162012

7 later devices reach CARESCAPE Central Station V2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+1K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+2K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+2K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+2K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401