The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Revolution Xr/d Digital Radiographic Imaging System With Tomosynthesis.
| Device ID | K051967 |
| 510k Number | K051967 |
| Device Name: | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS |
| Classification | System, X-ray, Stationary |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John L Schmidt |
| Correspondent | John L Schmidt GE HEALTHCARE 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | KPR |
| Subsequent Product Code | IZF |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-20 |
| Decision Date | 2005-08-09 |
| Summary: | summary |