510(k) Report

Devices descending from K913641

414 later devices reach Sophy NXT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+15K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+15K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—