510(k) K152393 ยท MUJ System, Planning, Radiation Therapy Treatment
Eclipse Treatment Planning System
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Sep 18, 2015 |
| Received | Aug 24, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Varian Medical Systems, Inc. Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6;
Model number: H48;
Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.