Chrysalis Intelligence · Sponsors · GEMSS HEALTHCARE CO., LTD.

GEMSS HEALTHCARE CO., LTD.

Paju-Si, KR · 3 510(k) clearances

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Total clearances
3
2023-11-02 → 2026-08-03
Last 12 months
1
Product codes
3
Most recent
2026-08-03
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 1 2026-08-03
OWB Interventional Fluoroscopic X-Ray System Class II Radiology 1 2023-11-16
KPR System, X-Ray, Stationary Class II Radiology 1 2023-11-02
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2026-08-03 K260236 XLITE IZL Class II Radiology
2023-11-16 K233200 XPLUS 35 Series (XPLUS 35, XPLUS 35FD) OWB Class II Radiology
2023-11-02 K230800 XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 KPR Class II Radiology
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence