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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K120514
Device Name CARDIOPACS
Original Applicant
LUMEDX
110, 110th ave ne
bellevue,  WA  98004
Original Contact chris pearce
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/21/2012
Decision Date 07/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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