510(k) K083264 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYAUTOPLAN 1.0
| Applicant | Raysearch Laboratories AB, Stockholm, SE |
| Decision | Substantially Equivalent, Jan 22, 2009 |
| Received | Nov 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2012 | RAYSEARCH LABORATORIES AB SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan
Intended use: t-RayAutoplan is a so Terminated |
MUJ | None listed |
| Sep 14, 2012 | RAYSEARCH LABORATORIES AB The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application a Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.