The following data is part of a premarket notification filed by U.s. Imaging, Inc. with the FDA for Modified X-ray Controls, Model Ed125l And Ed150l.
| Device ID | K881886 |
| 510k Number | K881886 |
| Device Name: | MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
| Contact | Charles Blouir |
| Correspondent | Charles Blouir U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-05 |
| Decision Date | 1988-08-04 |