The following data is part of a premarket notification filed by U.s. Imaging, Inc. with the FDA for U.s.i. Model 1012, Remote Fluoroscopic Control.
| Device ID | K900062 |
| 510k Number | K900062 |
| Device Name: | U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
| Contact | Martin Kulis |
| Correspondent | Martin Kulis 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 | 1990-01-03 |
| Decision Date | 1990-02-05 |