Medical Device Manufacturer · US , Echo , OR

DRGEM Corporation

13 submissions · 13 cleared · Since 2010
13
Total
13
Cleared
0
Denied

DRGEM Corporation — FDA 510(k) Submissions

DRGEM Corporation has submitted 13 FDA 510(k) premarket notifications since 2010, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Stationary, System, X-ray, Mobile, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
PROMO
K251443 · IZL System, X-ray, Mobile · Radiology
Aug 2025 105d
GXR-Series Diagnostic X-Ray System
K242019 · KPR System, X-ray, Stationary · Radiology
Jan 2025 181d
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
K242015 · IZL System, X-ray, Mobile · Radiology
Dec 2024 159d
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K232178 · KPR System, X-ray, Stationary · Radiology
Sep 2023 57d
GXR-Series Diagnostic X-Ray System
K202572 · KPR System, X-ray, Stationary · Radiology
Sep 2020 20d
DIAMOND-5A/6A/8A
K202156 · KPR System, X-ray, Stationary · Radiology
Sep 2020 45d
TOPAZ Mobile DR System
K201124 · IZL System, X-ray, Mobile · Radiology
May 2020 22d
DIAMOND-5A/6A/8A
K192453 · KPR System, X-ray, Stationary · Radiology
Oct 2019 22d
GXR-Series Diagnostic X-Ray System
K192364 · KPR System, X-ray, Stationary · Radiology
Sep 2019 27d
Topaz Mobile DR System
K183292 · IZL System, X-ray, Mobile · Radiology
May 2019 170d
RADMAX Digital Imaging Software
K182537 · LLZ System, Image Processing,... · Radiology
Mar 2019 175d
JADE Mobile X-Ray
K183388 · IZL System, X-ray, Mobile · Radiology
Feb 2019 61d
DIGITAL DIAGNOSTIC X-RAY SYSTEM
K102408 · KPR System, X-ray, Stationary · Radiology
Dec 2010 126d
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