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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 K052434
Device Name HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
Applicant
GE MEDICAL SYSTEMS
4 HAYOZMA ST. P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact ELI WERNER
Correspondent
GE MEDICAL SYSTEMS
4 HAYOZMA ST. P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact ELI WERNER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/06/2005
Decision Date 09/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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