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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 K253639
Device Name View
Applicant
Ge Healthcare
500 W. Monroe St.
Chicago,  IL  60661
Applicant Contact Tong Zhao
Correspondent
Ge Healthcare
500 W. Monroe St.
Chicago,  IL  60661
Correspondent Contact Tong Zhao
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/19/2025
Decision Date 01/08/2026
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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