510(k) K170355 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 6
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Feb 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170355
| 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: 6.0.0.24
Software Version: RayStation 6 Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.