The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Digital Lightbox.
| Device ID | K080608 |
| 510k Number | K080608 |
| Device Name: | DIGITAL LIGHTBOX |
| Classification | System, Image Processing, Radiological |
| Applicant | BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-04-17 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIGITAL LIGHTBOX 77332451 3972062 Dead/Cancelled |
BrainLAB AG 2007-11-18 |