HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM

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 Hrh-127-8 Head Array Coil For Ge Signa 3t Excite Mri System.

Pre-market Notification Details

Device IDK024352
510k NumberK024352
Device Name:HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
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 Received2002-12-30
Decision Date2003-01-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838080935 K024352 000
00884838080928 K024352 000
00884838066328 K024352 000
00884838065703 K024352 000

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