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


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K024352
Device Name HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
Original Applicant
MRI DEVICES CORP.
1515 paramount dr.
waukesha, 
WI 
53186

Original Contact thomas schubert
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 12/30/2002
Decision Date 01/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No