The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Rt Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis.
| Device ID | K142108 |
| 510k Number | K142108 |
| Device Name: | RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481140397 | K142108 | 000 |
| 04056481131500 | K142108 | 000 |
| 04056481007119 | K142108 | 000 |
| 04056481006853 | K142108 | 000 |
| 04056481000752 | K142108 | 000 |
| 04056481000585 | K142108 | 000 |
| 04056481000578 | K142108 | 000 |
| 04056481000561 | K142108 | 000 |