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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K013521
Device Name GEMINI IMAGING SYSTEM
Original Applicant
ADAC LABORATORIES
540 alder dr.
milpitas,  CA  95035
Original Contact coleen a coleman
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
KPS  
Date Received10/23/2001
Decision Date 11/07/2001
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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