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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K121948
Device Name CR 10-X DIGITIZER
Original Applicant
p.o. box 1927
brevard,  NC  28712 1927
Regulation Number892.1680
Classification Product Code
Date Received07/03/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls