IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

System, Nuclear Magnetic Resonance Imaging

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imrx System V1 And Imrisnv/imriscardio.

Pre-market Notification Details

Device IDK101813
510k NumberK101813
Device Name:IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant IMRIS, INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
ContactThomas M Tsakeris
CorrespondentThomas M Tsakeris
IMRIS, INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-29
Decision Date2010-10-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857534006189 K101813 000
00857534006172 K101813 000
00857534006165 K101813 000
00857534006158 K101813 000
00857534006141 K101813 000
00857534006127 K101813 000
00857534006110 K101813 000

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