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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 K012728
Device Name E-SCAN MRI SYSTEM
Applicant
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/15/2001
Decision Date 08/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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