510(k) Report

Devices descending from K000395

207 later devices reach Einstein Processing and Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K261306AI Contouring (VA10A)Varian Medical Systems20260—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—