510(k) Report

Devices descending from K013535

30 later devices reach Evtool Model # V. 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080601Ergo++ Version 1.73D Line Medical Systems S.R.L.2008292
+2K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+2K132971MonacoImpac Medical Systems, Inc.201374
+2K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+2K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090—
+2K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+3K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+3K151233MonacoImpac Medical Systems, Inc.201569
+3K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+4K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+4K193459Panther StereotacticProwess, Inc.20201—
+4K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+4K183037Monaco RTP SystemElekta, Inc.201856
+5K231825Panther TPSProwess, Inc.20230—
+5K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+5K211760Panther OISProwess, Inc.20210—
+5K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+5K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+5K190178Monaco RTP SystemElekta, Inc.201945
+6K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+6K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+6K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K213787Monaco RTP SystemElekta Solutions AB20222—
+7K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+8K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+8K223233Monaco RTP SystemElekta Solutions AB20231—
+9K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+9K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+10K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—