The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Digital Radiographic Imaging System.
| Device ID | K982196 |
| 510k Number | K982196 |
| Device Name: | DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-10-06 |
| Summary: | summary |