510(k) K030110 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
| Applicant | Mick Radio-Nuclear Instruments, Inc., Mt. Vernon NY, US |
| Decision | Substantially Equivalent, Apr 3, 2003 |
| Received | Jan 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Varian Medical Systems, Inc. VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.