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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 Spectroscopic
510(k) Number K011604
Device Name PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
Applicant
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNI  
Date Received05/24/2001
Decision Date 08/22/2001
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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