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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K042236
Device Name G-SCAN
Applicant
ESAOTE, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/18/2004
Decision Date 10/04/2004
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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