The following data is part of a premarket notification filed by Omnimedical with the FDA for Omnimedical Quad I.
| Device ID | K812400 |
| 510k Number | K812400 |
| Device Name: | OMNIMEDICAL QUAD I |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | OMNIMEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-20 |
| Decision Date | 1981-10-02 |