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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 K061930
Device Name INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
Applicant
Fonar Corp.
110 Marcus Dr.
Melville,  NY  11747
Applicant Contact LUCIANO BONANNI
Correspondent
Fonar Corp.
110 Marcus Dr.
Melville,  NY  11747
Correspondent Contact LUCIANO BONANNI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/07/2006
Decision Date 07/28/2006
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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