PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI

System, Nuclear Magnetic Resonance Spectroscopic

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Prostate Spectroscopy And Imaging Exam (prose) Software Option For Mri.

Pre-market Notification Details

Device IDK011604
510k NumberK011604
Device Name:PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
ClassificationSystem, Nuclear Magnetic Resonance Spectroscopic
Applicant GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeLNI  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-24
Decision Date2001-08-22
Summary:summary

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