IMRIS ONCOLOGY PACKAGE

System, Nuclear Magnetic Resonance Imaging

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imris Oncology Package.

Pre-market Notification Details

Device IDK121997
510k NumberK121997
Device Name:IMRIS ONCOLOGY PACKAGE
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb,  CA R3t 1n5
ContactSanjay Shah
CorrespondentSanjay Shah
IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb,  CA R3t 1n5
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-09
Decision Date2012-08-10
Summary:summary

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