510(k) K972324 ยท HAW Neurological Stereotaxic Instrument
LEKSELL STEREOTACTIC SYSTEM
| Applicant | Elekta Instrument AB, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 2, 1998 |
| Received | Jun 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2011 | Elekta, Inc. Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.