510(k) Report

Devices descending from K080601

29 later devices reach Ergo++ Version 1.7 through their predicates, nearest generation first.

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