510(k) K981112 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
MOBETRON
| Applicant | Intraop Medical, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 24, 1998 |
| Received | Mar 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2008 | Intraop Medical Corporation Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site. Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.