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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 K122427
Device Name CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
Original Applicant
CARESTREAM DENTAL LLC
1765 the exchange
atlanta,  GA  30339
Original Contact daniel hoefer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/10/2012
Decision Date 09/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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