The following data is part of a premarket notification filed by Drgem Corporation with the FDA for Topaz Mobile Dr System.
| Device ID | K201124 |
| 510k Number | K201124 |
| Device Name: | TOPAZ Mobile DR System |
| Classification | System, X-ray, Mobile |
| Applicant | DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro Gwangmyeong-si, KR 14322 |
| Contact | Ki-nam Yang |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-05-19 |