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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 K241350
Device Name Clarify DL
Applicant
Ge Medical Systems Israel, Functional Imaging
4 Hayozma St.
Tirat Hacarmel,  IL
Applicant Contact Mousa Elias Maysana
Correspondent
Ge Healthcare
3000 N Grandview Blvd. W 440
Waukesha,  WI  53188
Correspondent Contact Maysana Mousa Elias
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
KPS  
Date Received05/13/2024
Decision Date 01/03/2025
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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