The following data is part of a premarket notification filed by Universal X-ray with the FDA for Uxm Model 8188.
| Device ID | K840678 |
| 510k Number | K840678 |
| Device Name: | UXM MODEL 8188 |
| Classification | Collimator, Manual, Radiographic |
| Applicant | UNIVERSAL X-RAY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-03-16 |