510(k) K131807 ยท IYE Accelerator, Linear, Medical
HIGH ENERGY LINEAR ACCELERATOR
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Oct 11, 2013 |
| Received | Jun 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2013 | Varian Medical Systems, Inc. Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.
Manufactured by Varian Medical Systems
Pal Terminated |
MUJ | None listed |
| 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.