DRGEM Corporation - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
Denied
DRGEM Corporation has 13 FDA 510(k) cleared radiology devices. Based in Echo, US.
Latest FDA clearance: Aug 2025. Active since 2010.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
13 devices
Cleared
Aug 22, 2025
PROMO
Radiology
105d
Cleared
Jan 07, 2025
GXR-Series Diagnostic X-Ray System
Radiology
181d
Cleared
Dec 16, 2024
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
Radiology
159d
Cleared
Sep 19, 2023
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
Radiology
57d
Cleared
Sep 24, 2020
GXR-Series Diagnostic X-Ray System
Radiology
20d
Cleared
Sep 10, 2020
DIAMOND-5A/6A/8A
Radiology
45d
Cleared
May 19, 2020
TOPAZ Mobile DR System
Radiology
22d
Cleared
Oct 01, 2019
DIAMOND-5A/6A/8A
Radiology
22d
Cleared
Sep 26, 2019
GXR-Series Diagnostic X-Ray System
Radiology
27d
Cleared
May 15, 2019
Topaz Mobile DR System
Radiology
170d
Cleared
Mar 08, 2019
RADMAX Digital Imaging Software
Radiology
175d
Cleared
Feb 05, 2019
JADE Mobile X-Ray
Radiology
61d
Cleared
Dec 27, 2010
DIGITAL DIAGNOSTIC X-RAY SYSTEM
Radiology
126d