The following data is part of a premarket notification filed by Genesis Digital Imaging, Inc. with the FDA for Omni-vue System.
| Device ID | K073062 |
| 510k Number | K073062 |
| Device Name: | OMNI-VUE SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | GENESIS DIGITAL IMAGING, INC. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto GENESIS DIGITAL IMAGING, INC. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-30 |
| Decision Date | 2008-03-10 |
| Summary: | summary |