510(k) K100552 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSTATION VERSION 1.0
| Applicant | Raysearch Laboratories AB, Stockholm, SE |
| Decision | Substantially Equivalent, Mar 12, 2010 |
| Received | Feb 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2014 | RAYSEARCH LABORATORIES AB RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Terminated |
MUJ | None listed |
| Mar 28, 2014 | RAYSEARCH LABORATORIES AB RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. Terminated |
MUJ | None listed |
| Mar 26, 2012 | RAYSEARCH LABORATORIES AB RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System.
RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com
Designed for treatment plann Terminated |
MUJ | None listed |
| Dec 2, 2011 | RAYSEARCH LABORATORIES AB RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com
RayStation is a software system designed for Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.