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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 K913463
Device Name MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN
Applicant
Bruker Medical Imaging, Inc.
19 Fortune Dr.
Billerica,  MA  01821
Applicant Contact KENNETH R PASTOTNIK
Correspondent
Bruker Medical Imaging, Inc.
19 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact KENNETH R PASTOTNIK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/05/1991
Decision Date 11/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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