AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12

Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K033292
Device Name AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
Applicant
IGC-MEDICAL ADVANCES, INC.
10437 innovation dr.
milwaukee, 
WI 
53226

Applicant Contact anthony dietzler
Correspondent
IGC-MEDICAL ADVANCES, INC.
10437 innovation dr.
milwaukee, 
WI 
53226

Correspodent Contact anthony dietzler
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 10/14/2003
Decision Date 11/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No