510(k) K123815 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 11, 2013 |
| Received | Dec 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2015 | Varian Medical Systems Inc Surface Applicator Set with Leipzig-style Cone.
Brachytherapy applicator set. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.