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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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