510(k) K181404 ยท IYE Accelerator, Linear, Medical
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 28, 2018 |
| Received | May 29, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2019 | Varian Medical Systems, Inc. Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - P Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.