K130842 is an FDA 510(k) clearance for the ALLURA XPER FD OR TABLE SERIES. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on May 21, 2013, 55 days after receiving the submission on March 27, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K130842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2013 |
| Decision Date | May 21, 2013 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |