510(k) Report

Devices descending from K926008

137 later devices reach Pinnacle 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K190978RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.202001
+9K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+9K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+9K180308PreludeMedcom GmbH20180—
+9K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated201701
+9K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+9K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+9K161146Radixact Treatment Delivery SystemAccuray Incorporated201631
+9K152488Onrad Treatment SystemAccuray Incorporated20150—
+10K211841MRI PlannerSpectronic Medical AB20220—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K214081MRCAT Head & NeckPhilips OY20220—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated20201—
+10K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated20180—
+10K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+10K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+10K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+11K223159Radixact Treatment Delivery SystemAccuray Incorporated20230—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—
+11K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+14K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+15K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+16K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+17K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+18K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+19K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—