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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 K000908
Device Name SKYLIGHT IMAGING SYSTEM
Original Applicant
ADAC LABORATORIES
540 alder dr.
milpitas,  CA  95035
Original Contact janice e brown
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/21/2000
Decision Date 04/05/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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