OBC-096 BREAST ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K002539
Device Name OBC-096 BREAST ARRAY COIL
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 08/16/2000
Decision Date 08/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No