510(k) Report

Devices descending from K131414

10 later devices reach Carescape Monitor B850 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191323Carescape B850GE Healthcare Finland Oy202071
+1K191249Carescape B450GE Healthcare Finland Oy20204—
+2K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+2K213336Carescape B850, E-musbGE Healthcare Finland Oy202221
+2K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy202313
+4K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—