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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 K051754
Device Name ORTHOSCAN, ORTHOSCAN HD
Applicant
ORTHOSCAN, INC.
8585 E HARTFORD DRIVE
SCOTTSDALE,  AZ  85255
Applicant Contact ARLEN ISSETTE
Correspondent
ORTHOSCAN, INC.
8585 E HARTFORD DRIVE
SCOTTSDALE,  AZ  85255
Correspondent Contact ARLEN ISSETTE
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received06/29/2005
Decision Date 08/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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