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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K122646
Models 800629, 800630
Device Name DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
Original Applicant
3545 sw 47th ave.
gainesville,  FL  32608
Original Contact lisa simpson
Regulation Number892.1000
Classification Product Code
Date Received08/30/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No