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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 K093284
Device Name 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
Applicant
INVIVO CORPORATION
3545 SW 47TH AVE
GAINESVILLE,  FL  32608
Applicant Contact ELIZABETH WHEELER
Correspondent
INVIVO CORPORATION
3545 SW 47TH AVE
GAINESVILLE,  FL  32608
Correspondent Contact ELIZABETH WHEELER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/20/2009
Decision Date 02/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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