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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 K173816
Device Name NM/CT 850, NM/CT 860
Applicant
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Applicant Contact George Mashour
Correspondent
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Correspondent Contact George Mashour
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received12/15/2017
Decision Date 04/17/2018
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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