MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS

Coil, Magnetic Resonance, Specialty

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Ecoil Imaging System For Philips.

Pre-market Notification Details

Device IDK063342
510k NumberK063342
Device Name:MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
ContactLisa A Ewing
CorrespondentLisa A Ewing
MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-06
Decision Date2006-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10616258009268 K063342 000
00850011472088 K063342 000
00850011472095 K063342 000
00850011472101 K063342 000
00616258009070 K063342 000
00616258009087 K063342 000
00616258009100 K063342 000
00616258009117 K063342 000
00616258009131 K063342 000
00616258009148 K063342 000
00616258009162 K063342 000
00616258009179 K063342 000
00850011472019 K063342 000

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