Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DRGEM Corporation — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

105 daysmedian FDA review time
175 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation2026-05-141220
K251443PROMODRGEM Corporation2025-08-221050
K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation2025-01-071810
K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation2024-12-161590
K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GDRGEM Corporation2023-09-19570
K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation2020-09-24200
K202156DIAMOND-5A/6A/8ADRGEM Corporation2020-09-10450
K201124TOPAZ Mobile DR SystemDRGEM Corporation2020-05-19220
K192453DIAMOND-5A/6A/8ADRGEM Corporation2019-10-01220
K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation2019-09-26270
K183292Topaz Mobile DR SystemDRGEM Corporation2019-05-151700
K182537RADMAX Digital Imaging SoftwareDRGEM Corporation2019-03-081750
K183388JADE Mobile X-RayDRGEM Corporation2019-02-05610
K102408DIGITAL DIAGNOSTIC X-RAY SYSTEMDRGEM Corporation2010-12-271260

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda