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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cabinet,x-ray system
510(k) Number K122428
Model PATH VISION
Device Name FAXITRON SPECIEN RADIOGRAPHY SYSTEM
Original Applicant
FAXITRON BIOPTICS LLC
3440 e. britannia drive
suite 150
tucson,  AZ  85706
Original Contact douglas c wiegman
Regulation Number892.1680
Classification Product Code
MWP  
Date Received08/09/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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