FDA 510(k) Applications Submitted by DRGEM CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K102408 08/23/2010 DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM CORPORATION
K201124 04/27/2020 TOPAZ Mobile DR System DRGEM Corporation
K202156 07/27/2020 DIAMOND-5A/6A/8A DRGEM Corporation
K192364 08/30/2019 GXR-Series Diagnostic X-Ray System DRGEM Corporation
K202572 09/04/2020 GXR-Series Diagnostic X-Ray System DRGEM Corporation
K192453 09/09/2019 DIAMOND-5A/6A/8A DRGEM Corporation
K182537 09/14/2018 RADMAX Digital Imaging Software DRGEM Corporation
K183292 11/26/2018 Topaz Mobile DR System DRGEM Corporation
K183388 12/06/2018 JADE Mobile X-Ray DRGEM Corporation
K232178 07/24/2023 GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) DRGEM Corporation


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