510(k) K140528 ยท IYE Accelerator, Linear, Medical
TRUE BEAM, TRUE BEAM STX, EDGE
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Sep 5, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2018 | Varian Medical Systems TrueBeam Radiotherapy Delivery System version 2.0 and 2.5
EDGE Radiotherapy Delivery System version 2.0 and 2.5
Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and Terminated |
IYE | None listed |
| Jun 30, 2016 | Vision RT Ltd TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for l Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.