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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 K221932
Device Name Omni Legend
Applicant
Ge Healthcare
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Applicant Contact Alexandra Lifshits
Correspondent
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 Received07/01/2022
Decision Date 09/02/2022
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
Recalls CDRH Recalls
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