510(k) K030439 ยท IYE Accelerator, Linear, Medical
HEADFIX
| Applicant | Medical Intelligence Medizintechnik GmbH, Stamford CT, US |
| Decision | Substantially Equivalent, May 8, 2003 |
| Received | Feb 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2010 | Elekta, Inc. Elekta VBH Head FIX
The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.