510(k) K040541 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 22, 2004 |
| Received | Mar 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2006 | Varian Medical Systems GammaWin software, part number GM11019110, versions up to and including 1.62, for the MammoSource radionuclide applicator system, for radiation therapy. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.