The following data is part of a premarket notification filed by Omnimedical with the FDA for Omnimedical Automatic 1001.
| Device ID | K790673 |
| 510k Number | K790673 |
| Device Name: | OMNIMEDICAL AUTOMATIC 1001 |
| Classification | System, X-ray, Mobile |
| Applicant | OMNIMEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-09 |
| Decision Date | 1979-05-04 |