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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K260236
Device Name XLITE
Applicant
GEMSS HEALTHCARE CO., LTD.
1f, 822, Bogwang-Ro, Gwangtan-Myeon
Paju-Si,  KR 10952
Applicant Contact Jeongbin Park
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number892.1720
Classification Product Code
IZL  
Date Received01/26/2026
Decision Date 08/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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