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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K113708
Device Name ORTHOSCAN MOBILE DI MINI C-ARM
Original Applicant
ORTHOSCAN, INC.
8212 e. evans road
scottsdale,  AZ  85260
Original Contact chris eaves
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received12/16/2011
Decision Date 01/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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