XLITE— 510(k) K260236

Name: FDA 510(k) clearance K260236
Creator: U.S. Food and Drug Administration
Published: 2026-08-03

Substantially Equivalent

GEMSS HEALTHCARE CO., LTD.

FDA 510(k) clearance K260236 for XLITE, Substantially Equivalent on 2026-08-03. Applicant: GEMSS HEALTHCARE CO., LTD.. Device class: 2.

Clearance details

Applicant: GEMSS HEALTHCARE CO., LTD.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2026-01-26
Decision date: 2026-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZL

view all

K253058 — Portable DR Imaging System2026-06-18
K260085 — RAYMO Mobile X-ray System (Model: RAYMO)2026-05-14
K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System2026-03-11
K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)2026-02-23
K250976 — Airbile-1002025-12-19

More clearances from GEMSS HEALTHCARE CO., LTD.

view all

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.