The following data is part of a premarket notification filed by Eigen Llc with the FDA for 3-d Imaging Workstation.
| Device ID | K081093 |
| 510k Number | K081093 |
| Device Name: | 3-D IMAGING WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | EIGEN LLC 13366 GRASS VALLEY AVE. Grass Valley, CA 95945 |
| Contact | Mark A Hoffman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-17 |
| Decision Date | 2008-05-01 |
| Summary: | summary |