ClearanceBrief
510(k) K180379 ยท MUJ System, Planning, Radiation Therapy Treatment

RayStation 7

ApplicantRaySearch Laboratories AB (PUBL), Stockholm, SE
DecisionSubstantially Equivalent, Apr 25, 2018
ReceivedFeb 12, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180379

DateFirm and productCodeLinked 510(k)
Sep 2, 2025RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.
Open, Classified		 MUJNone listed
Feb 19, 2025RAYSEARCH LABORATORIES AB
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Open, Classified		 MUJNone listed
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJNone listed
Nov 12, 2018RAYSEARCH LABORATORIES AB
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Terminated		 MUJNone listed
Sep 21, 2018RAYSEARCH LABORATORIES AB
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Terminated		 MUJNone listed
Jun 29, 2018RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation
Terminated		 MUJNone listed
Jun 6, 2018RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment plan
Terminated		 MUJNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.