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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
Recalls CDRH Recalls
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