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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 K111445
Device Name DISCOVERY NM 630
Applicant
GE HEALTHCARE
4 HAYOZMA STREET
TIRAT HACARMEL,  IL 30200
Applicant Contact TAL BRESLER-STRAMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/24/2011
Decision Date 06/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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