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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, Tomography, Computed
510(k) Number K253686
Device Name True Definition DL
Applicant
Ge Healthcare Japan Corporation
7-127, Asahigaoka, 4-Chome
Hino-Shi, Tokyo,  JP 191-8503
Applicant Contact Yonghui Han
Correspondent
Ge Healthcare Japan Corporation
7-127, Asahigaoka, 4-Chome
Hino-Shi, Tokyo,  JP 191-8503
Correspondent Contact Yonghui Han
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/21/2025
Decision Date 03/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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