510(k) K171536 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Jun 27, 2017 |
| Received | May 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2.
2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7.
3. RayStation 6 Service Pa Open, Classified |
MUJ | None listed |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6
Software Version: RayStation 6 Service Pack 1, 2 and 3 Open, Classified |
MUJ | None listed |
| Mar 28, 2018 | RAYSEARCH LABORATORIES AB RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0
Product Usage: Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. Th Terminated |
MUJ | None listed |
| Jan 26, 2018 | RAYSEARCH LABORATORIES AB Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19
UDI: 0735000201006820171 Terminated |
MUJ | None listed |
| Nov 20, 2017 | RAYSEARCH LABORATORIES AB RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) .
Intended Use: software system designed for treatme Terminated |
MUJ | None listed |
| Jul 17, 2017 | RAYSEARCH LABORATORIES AB RayStation
Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.