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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 K041218
Device Name GRIFFIN SPECT/CT IMAGING SYSTEM
Original Applicant
ADAC LABORATORIES
540 alder dr.
milpitas,  CA  95035
Original Contact coleen a coleman
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/10/2004
Decision Date 05/24/2004
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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