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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 K133174
Device Name ORTHOSCAN FD MINI C-ARM
Applicant
Orthoscan, Inc.
8212 E Evans Rd.
8224 E Evans Rd.
Scottsdale,  AZ  85260
Applicant Contact ADAM MENZIES
Correspondent
Orthoscan, Inc.
8212 E Evans Rd.
8224 E Evans Rd.
Scottsdale,  AZ  85260
Correspondent Contact ADAM MENZIES
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
MQB  
Date Received10/17/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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