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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 K223212
Device Name Precision DL
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Applicant Contact George Mashour
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Correspondent Contact George Mashour
Regulation Number892.1200
Classification Product Code
Date Received10/17/2022
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No