The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Elements Image Fusion Angio.
| Device ID | K190042 |
| 510k Number | K190042 |
| Device Name: | Brainlab Elements Image Fusion Angio |
| Classification | System, Image Processing, Radiological |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munchen, DE 81829 |
| Contact | Rainer Birkenbach |
| Correspondent | Alexander Schwiersch Brainlab AG Olof-Palme-Str. 9 Munchen, DE 81829 |
| Product Code | LLZ |
| Subsequent Product Code | JAK |
| Subsequent Product Code | LHN |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-09 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481138530 | K190042 | 000 |