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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 K072850
Device Name MRI SYSTEM, MODEL MAGFINDER II / AI 3200
Applicant
ADVANCED IMAGING LABORATORY
30 NORTHPORT AVE.
SOUND BEACH,  NY  11789
Applicant Contact STEPHEN T MLCOCH
Correspondent
ADVANCED IMAGING LABORATORY
30 NORTHPORT AVE.
SOUND BEACH,  NY  11789
Correspondent Contact STEPHEN T MLCOCH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/04/2007
Decision Date 11/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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