510(k) K912555 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
| Applicant | Rts Technology, Inc., North Andover MA, US |
| Decision | Substantially Equivalent, Aug 2, 1991 |
| Received | Jun 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2007 | Varian Medical Systems GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA Terminated |
JAQ | None listed |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.