510(k) K970586 ยท IYE Accelerator, Linear, Medical
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
| Applicant | Brainlab Med. Computersysteme GmbH, 85551 Heimstetten, DE |
| Decision | Substantially Equivalent, May 12, 1997 |
| Received | Feb 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2009 | Brainlab AG BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany.
The mMLC is intended to assist the radiation oncologist in the delivery of radiation to Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.