510(k) K141860 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSTATION
| Applicant | Raysearch Laboratories AB, Stockholm, SE |
| Decision | Substantially Equivalent, Oct 23, 2014 |
| Received | Jul 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7
Software Version: RayStation 4.5.1, 4. Open, Classified |
MUJ | None listed |
| May 25, 2016 | RAYSEARCH LABORATORIES AB RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. Terminated |
MUJ | None listed |
| Sep 17, 2015 | RAYSEARCH LABORATORIES AB Radiation Therapy Treatment Planning System software
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set- Terminated |
MUJ | None listed |
| Aug 25, 2015 | RAYSEARCH LABORATORIES AB RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. Terminated |
MUJ | None listed |
| Mar 20, 2015 | RAYSEARCH LABORATORIES AB RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, r Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.