510(k) K964607 ยท IWD Device, Beam Limiting, Teletherapy, Radionuclide
THERATON 1000E
| Applicant | Theratronics, Inc., Kanata, Ontario, Canada, CA |
| Decision | Substantially Equivalent, May 28, 1997 |
| Received | Nov 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 1000E 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.