DIGITAL LIGHTBOX
System, Image Processing, Radiological
BRAINLAB AG
The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Digital Lightbox.
Pre-market Notification Details
| Device ID | K093117 |
| 510k Number | K093117 |
| Device Name: | DIGITAL LIGHTBOX |
| Classification | System, Image Processing, Radiological |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 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 | 2009-10-02 |
| Decision Date | 2009-12-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481006877 | K093117 | 000 |
| 04056481006846 | K093117 | 000 |
| 04056481001797 | K093117 | 000 |
| 04056481000431 | K093117 | 000 |
| 04056481000363 | K093117 | 000 |
| 04056481000356 | K093117 | 000 |
Trademark Results [DIGITAL LIGHTBOX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGITAL LIGHTBOX 77332451 3972062 Dead/Cancelled |
BrainLAB AG 2007-11-18 |
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