The following data is part of a premarket notification filed by General X-ray, Inc. with the FDA for X-ray Units, Gx-101, Ucis-510 And Gx-111.
| Device ID | K790451 |
| 510k Number | K790451 |
| Device Name: | X-RAY UNITS, GX-101, UCIS-510 AND GX-111 |
| Classification | System, X-ray, Mobile |
| Applicant | GENERAL X-RAY, INC. 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 | 1979-03-05 |
| Decision Date | 1979-03-28 |