XLITE— 510(k) K260236
Substantially EquivalentGEMSS HEALTHCARE CO., LTD.
FDA 510(k) clearance K260236 for XLITE, Substantially Equivalent on 2026-08-03. Applicant: GEMSS HEALTHCARE CO., LTD.. Device class: 2.
Summary
GEMSS Healthcare's XLITE is filed under product code IZL, mobile x-ray systems. The record gives no other model numbers.
Class II, 21 CFR 892.1720. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The record flags it as a third-party review.
GEMSS filed from Paju-Si, South Korea. The decision came 189 calendar days after FDA received it (January 26 to August 3, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- GEMSS HEALTHCARE CO., LTD.
- Product code
- Product code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paju-Si, KR
Recent devices under product code IZL
view allMore clearances from GEMSS HEALTHCARE CO., LTD.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.