K221144 is an FDA 510(k) clearance for the PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Radisen Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 13, 2022, 23 days after receiving the submission on April 20, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K221144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2022 |
| Decision Date | May 13, 2022 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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 |