The following data is part of a premarket notification filed by X-ray Systems with the FDA for Mount Tube Radiographic.
| Device ID | K853682 |
| 510k Number | K853682 |
| Device Name: | MOUNT TUBE RADIOGRAPHIC |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
| Contact | Drumb |
| Correspondent | Drumb X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1985-09-19 |