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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 K050996
Device Name O-ARM IMAGING SYSTEM
Applicant
Breakaway Imaging, LLC
300 Foster St.
Littleton,  MA  01460
Applicant Contact WOLFGANG KRULL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact JEFF RONGERO
Regulation Number892.1650
Classification Product Code
OXO  
Date Received04/20/2005
Decision Date 05/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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