The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio.
| Device ID | K212420 |
| 510k Number | K212420 |
| Device Name: | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
| Classification | System, Image Processing, Radiological |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 80809 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 80809 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481143015 | K212420 | 000 |