K132261 is an FDA 510(k) clearance for the DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS). This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on November 18, 2013, 122 days after receiving the submission on July 19, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K132261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2013 |
| Decision Date | November 18, 2013 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF — System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |