510(k) K142108 ยท MUJ System, Planning, Radiation Therapy Treatment
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Dec 16, 2014 |
| Received | Aug 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2019 | Brainlab AG RT Elements
Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected:
- Cranial SRS 1.0.0 Terminated |
MUJ | None listed |
| Nov 5, 2015 | Brainlab AG RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Terminated |
MUJ | None listed |
| Nov 5, 2015 | Brainlab AG RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.