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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 K023686
Device Name AURORA MR-GUIDED INTERVENTIONAL SYSTEM
Applicant
Aurora Imaging Technology, Inc.
39 High St.
North Andover,  MA  01845
Applicant Contact ALAN OSLAN
Correspondent
Aurora Imaging Technology, Inc.
39 High St.
North Andover,  MA  01845
Correspondent Contact ALAN OSLAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/01/2002
Decision Date 01/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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