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DRGEM Corporation

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories3
Latest FDA decision2026-05-14
TypeNumberDevice NameCodeDateActions
510(k) K260085 RAYMO Mobile X-ray System (Model: RAYMO)IZL2026-05-14 View
510(k) K251443 PROMOIZL2025-08-22 View
510(k) K242019 GXR-Series Diagnostic X-Ray SystemKPR2025-01-07 View
510(k) K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZL2024-12-16 View
510(k) K232178 GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)KPR2023-09-19 View
510(k) K202572 GXR-Series Diagnostic X-Ray SystemKPR2020-09-24 View
510(k) K202156 DIAMOND-5A/6A/8AKPR2020-09-10 View
510(k) K201124 TOPAZ Mobile DR SystemIZL2020-05-19 View
510(k) K192453 DIAMOND-5A/6A/8AKPR2019-10-01 View
510(k) K192364 GXR-Series Diagnostic X-Ray SystemKPR2019-09-26 View
510(k) K183292 Topaz Mobile DR SystemIZL2019-05-15 View
510(k) K182537 RADMAX Digital Imaging SoftwareLLZ2019-03-08 View
510(k) K183388 JADE Mobile X-RayIZL2019-02-05 View
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