K183292 is an FDA 510(k) clearance for the Topaz Mobile DR System. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on May 15, 2019, 170 days after receiving the submission on November 26, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K183292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2018 |
| Decision Date | May 15, 2019 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |