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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K051025
Device Name FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Applicant
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Applicant Contact DANIEL F PHELAN
Correspondent
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact DANIEL F PHELAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received04/22/2005
Decision Date 05/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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