ISA-21 INTERVENTIONAL SPINE ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K021631
Device Name ISA-21 INTERVENTIONAL SPINE 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 05/17/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No