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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 K120388
Device Name INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Original Applicant
HOLOGIC, INC.
35 crosby dr.
bedford,  MA  01730
Original Contact eileen m boyle
Regulation Number892.1650
Classification Product Code
OXO  
Date Received02/07/2012
Decision Date 04/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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