The following data is part of a premarket notification filed by General Electric Co. with the FDA for Modification To: Revolution Xr/d Digital Radiographic Imaging System With Image Pasting And Autopositioning.
| Device ID | K050704 |
| 510k Number | K050704 |
| Device Name: | MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING |
| Classification | System, X-ray, Stationary |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | John L Schmidt |
| Correspondent | John L Schmidt GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-08 |
| Summary: | summary |