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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 K900026
Device Name BRUKER R28 WHOLE-BODY MR SCANNER
Applicant
BRUKER MEDICAL IMAGING, INC.
5111 ACADEMY DR.
LISLE,  IL  60532
Applicant Contact KENNETH R PASTOTNIK
Correspondent
BRUKER MEDICAL IMAGING, INC.
5111 ACADEMY DR.
LISLE,  IL  60532
Correspondent Contact KENNETH R PASTOTNIK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/03/1990
Decision Date 04/30/1990
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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