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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 K153402
Device Name Discovery NM/CT 670 CZT
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 Received11/24/2015
Decision Date 01/21/2016
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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