510(k) K983917 ยท IWB System, Radiation Therapy, Radionuclide
THERATRON ELITE
| Applicant | Theratronics, Inc., Kanata, Ontario, Canada, CA |
| Decision | Substantially Equivalent, Dec 4, 1998 |
| Received | Nov 4, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983917
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 80 Cobalt Radiotherapy Terminated |
IWB | None listed |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 100 Cobalt Radiotherapy Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.