DRGEM Corporation
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251443 | PROMO | August 22, 2025 |
| K242019 | GXR-Series Diagnostic X-Ray System | January 7, 2025 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | December 16, 2024 |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | September 19, 2023 |
| K202572 | GXR-Series Diagnostic X-Ray System | September 24, 2020 |
| K202156 | DIAMOND-5A/6A/8A | September 10, 2020 |
| K201124 | TOPAZ Mobile DR System | May 19, 2020 |
| K192453 | DIAMOND-5A/6A/8A | October 1, 2019 |
| K192364 | GXR-Series Diagnostic X-Ray System | September 26, 2019 |
| K183292 | Topaz Mobile DR System | May 15, 2019 |
| K182537 | RADMAX Digital Imaging Software | March 8, 2019 |
| K183388 | JADE Mobile X-Ray | February 5, 2019 |
| K102408 | DIGITAL DIAGNOSTIC X-RAY SYSTEM | December 27, 2010 |