510(k) K143224 ยท IYE Accelerator, Linear, Medical
TrueBeam-TrueBeam STx-Edge
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Nov 10, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143224
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.