K140551 is an FDA 510(k) clearance for the PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on August 1, 2014, 150 days after receiving the submission on March 4, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K140551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2014 |
| Decision Date | August 01, 2014 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |