Chrysalis Intelligence · Sponsors · DRGEM Corporation

DRGEM Corporation

Gwangmyeong-Si, KR · 8 510(k) clearances

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Total clearances
8
2020-05-19 → 2026-05-14
Last 12 months
1
Product codes
2
Most recent
2026-05-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IZL System, X-Ray, Mobile Class II Radiology 4 2026-05-14
KPR System, X-Ray, Stationary Class II Radiology 4 2025-01-07
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-05-14 K260085 RAYMO Mobile X-ray System (Model: RAYMO) IZL Class II Radiology
2025-08-22 K251443 PROMO IZL Class II Radiology
2025-01-07 K242019 GXR-Series Diagnostic X-Ray System KPR Class II Radiology
2024-12-16 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) IZL Class II Radiology
2023-09-19 K232178 GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) KPR Class II Radiology
2020-09-24 K202572 GXR-Series Diagnostic X-Ray System KPR Class II Radiology
2020-09-10 K202156 DIAMOND-5A/6A/8A KPR Class II Radiology
2020-05-19 K201124 TOPAZ Mobile DR System IZL Class II Radiology
Data source: openFDA · Generated 2026-08-23 08:58 · Last ingest 2026-08-23T12:58:54.311501 · Pipeline: Chrysalis Intelligence