510(k) K053584 ยท MUJ System, Planning, Radiation Therapy Treatment
IPLAN RT DOSE
| Applicant | Brainlab AG, Heimstetten, DE |
| Decision | Substantially Equivalent, Jul 12, 2006 |
| Received | Dec 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2015 | Brainlab AG iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, an Terminated |
MUJ | None listed |
| Jan 15, 2015 | Brainlab AG iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial les Terminated |
MUJ | None listed |
| Jul 3, 2007 | Brainlab AG BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammert Terminated |
IWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.