DRGEM Corporation - FDA 510(k) Cleared Devices
Recent clearances: RAYMO Mobile X-ray System (Model: RAYMO), PROMO, GXR-Series Diagnostic X-Ray System
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - DRGEM Corporation Radiology ✕
14 devices
Cleared
May 14, 2026
RAYMO Mobile X-ray System (Model: RAYMO)
Radiology
122d
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