The following data is part of a premarket notification filed by Ito X-ray Corp. with the FDA for Collimax X-ray Collimator # R-182.
| Device ID | K801168 |
| 510k Number | K801168 |
| Device Name: | COLLIMAX X-RAY COLLIMATOR # R-182 |
| Classification | Collimator, Manual, Radiographic |
| Applicant | ITO X-RAY CORP. 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 | 1980-05-15 |
| Decision Date | 1980-07-08 |