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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 K060344
Device Name O-ARM IMAGING SYSTEM
Applicant
BREAKAWAY IMAGING, LLC
300 FOSTER STREET
LITTLETON,  MA  01460
Applicant Contact RICK GRANT
Correspondent
BREAKAWAY IMAGING, LLC
300 FOSTER STREET
LITTLETON,  MA  01460
Correspondent Contact RICK GRANT
Regulation Number892.1650
Classification Product Code
OXO  
Date Received02/10/2006
Decision Date 03/29/2006
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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