510(k) K004022 ยท IYE Accelerator, Linear, Medical
M3 (MIRCO-MULTILEAF COLLIMATOR
| Applicant | Brainlab AG, Heimstetten, DE |
| Decision | Substantially Equivalent, Mar 26, 2002 |
| Received | Dec 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2009 | Brainlab AG BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany.
The mMLC is intended to assist the radiation oncologis Terminated |
IYE | None listed |
| Jul 2, 2009 | Brainlab AG BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany.
The m MLC is intended to assist the radiat Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.