K260236
- 510(k) number
- K260236
- Device name
- XLITE
- Applicant
- GEMSS HEALTHCARE CO., LTD. KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2026-08-03
- Date received
- 2026-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K260236.pdf
Official FDA record: K260236
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.