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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
Device Name DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
Applicant
INVIVO CORPORATION
3545 SW 47TH AVE.
GAINESVILLE,  FL  32608
Applicant Contact Lisa Simpson
Correspondent
INVIVO CORPORATION
3545 SW 47TH AVE.
GAINESVILLE,  FL  32608
Correspondent Contact Lisa Simpson
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/30/2012
Decision Date 11/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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