510(k) K120387 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSTATION
| Applicant | Raysearch Laboratories AB, Stockholm, SE |
| Decision | Substantially Equivalent, Apr 6, 2012 |
| Received | Feb 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2015 | RAYSEARCH LABORATORIES AB RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment
Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatmen Terminated |
MUJ | None listed |
| 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 |
| Nov 14, 2013 | RAYSEARCH LABORATORIES AB Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Terminated |
MUJ | None listed |
| May 28, 2013 | RAYSEARCH LABORATORIES AB RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment.
RayStation is a software system designed for treatme Terminated |
MUJ | None listed |
| Sep 6, 2012 | RAYSEARCH LABORATORIES AB Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
RayStation is a software system design Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.