K051967 is an FDA 510(k) clearance for the REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on August 9, 2005, 20 days after receiving the submission on July 20, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K051967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2005 |
| Decision Date | August 09, 2005 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |