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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K241665
Device Name Omni Legend
Applicant
Ge Medical Systems Israel, Functional Imaging
(Ge Healthcare)
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Applicant Contact Alexandra Lifshits
Correspondent
Ge Medical Systems Israel, Functional Imaging
(Ge Healthcare)
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Correspondent Contact Alexandra Lifshits
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/10/2024
Decision Date 08/08/2024
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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