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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K253486
Device Name SKIA-Head (Model: SKIA-ST00)
Applicant
Skia, Inc.
1502, 288 Digital-Ro, Guro-Gu
Seoul,  KR 08390
Applicant Contact Jong Myoung Lee
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/17/2025
Decision Date 02/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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