510(k) K073018 ยท IYE Accelerator, Linear, Medical
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Jan 23, 2008 |
| Received | Oct 25, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Brainlab AG BRAINLAB; FRAMELESS SRS QA TARGET POINTER
Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.