QSC-63-INT SHOULDER ARRAY COIL SET

Coil, Magnetic Resonance, Specialty

MRI DEVICES CORP.

The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Qsc-63-int Shoulder Array Coil Set.

Pre-market Notification Details

Device IDK022910
510k NumberK022910
Device Name:QSC-63-INT SHOULDER ARRAY COIL SET
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
ContactThomas Schubert
CorrespondentThomas Schubert
MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-03
Decision Date2002-10-03

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