Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list DRGEM Corporation with 14 510(k) clearances. The most recent is a 510(k) clearance dated May 14, 2026: RAYMO Mobile X-ray System (Model: RAYMO).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 14, 2026 | RAYMO Mobile X-ray System (Model: RAYMO)K260085 · IZL | 510(k) clearances |
| Aug 22, 2025 | PROMOK251443 · IZL | 510(k) clearances |
| Jan 7, 2025 | GXR-Series Diagnostic X-Ray SystemK242019 · KPR | 510(k) clearances |
| Dec 16, 2024 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)K242015 · IZL | 510(k) clearances |
| Sep 19, 2023 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)K232178 · KPR | 510(k) clearances |
| Sep 24, 2020 | GXR-Series Diagnostic X-Ray SystemK202572 · KPR | 510(k) clearances |
| Sep 10, 2020 | DIAMOND-5A/6A/8AK202156 · KPR | 510(k) clearances |
| May 19, 2020 | TOPAZ Mobile DR SystemK201124 · IZL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
