MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K023848
Device Name MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
Original Applicant
IGC-MEDICAL ADVANCES, INC.
10437 innovation dr.
milwaukee, 
WI 
53226

Original Contact r. jerry frohlich
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/19/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No