510(k) K070574 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
FLEXITRON
| Applicant | Isodose Control B.V., Veenendaal, NL |
| Decision | Substantially Equivalent, Apr 13, 2007 |
| Received | Feb 28, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K070574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2019 | Nucletron BV There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the in Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.