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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
Recalls CDRH Recalls
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