The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Elements Viewer.
| Device ID | K191014 |
| 510k Number | K191014 |
| Device Name: | Elements Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Oliver Fleig |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2020-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481141776 | K191014 | 000 |
| 04056481142513 | K191014 | 000 |
| 04056481143619 | K191014 | 000 |
| 04056481143800 | K191014 | 000 |