510(k) K102024 ยท IYE Accelerator, Linear, Medical
RPM RESPIRATORY GATING SYSTEM
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Oct 15, 2010 |
| Received | Jul 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2
Product Usage: The RPM device is to be used to characterize the patients respiratory motion informatio Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.