K133524 is an FDA 510(k) clearance for the PVMED DDR 2430T. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Portavision Medical, LLC (Kenner, US). The FDA issued a Cleared decision on April 16, 2014, 152 days after receiving the submission on November 15, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K133524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2013 |
| Decision Date | April 16, 2014 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |