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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 K052077
Device Name G-SCAN CERVICAL SPINE COIL
Applicant
Esaote, S.p.A.
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
Esaote, S.p.A.
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/01/2005
Decision Date 08/16/2005
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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