510(k) K132705 ยท IYE Accelerator, Linear, Medical
UNIQUE
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Oct 31, 2013 |
| Received | Aug 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2013 | Varian Medical Systems, Inc. C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US.
Product Usage: T Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.