510(k) Report

Devices descending from K010975

108 later devices reach Eclipse 6.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+17K250963PlanOne 1Cosylab Jsc, Control System Laboratory20250—
+17K242378Eclipse Treatment Planning System (18.1)Varian Medical Systems20241—
+17K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+17K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+18K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—
+18K260750Virtual Cone (1.0)Varian Medical Systems, Inc.20260—
+18K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+19K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—