FDA 510(k) Applications Submitted by Ki-Nam Yang

FDA 510(k) Number Submission Date Device Name Applicant
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


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