K181631 is an FDA 510(k) clearance for the GR40CW. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB).
Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 20, 2018, 30 days after receiving the submission on June 20, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K181631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2018 |
| Decision Date | July 20, 2018 |
| Days to Decision | 30 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 |