MODIFICATION TO AURORA MRI SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K073425
Device Name MODIFICATION TO AURORA MRI SYSTEM
Applicant
AURORA IMAGING TECHNOLOGY, INC.
39 high st.
north andover, 
MA 
01845

Applicant Contact michael a douglas
Correspondent
AURORA IMAGING TECHNOLOGY, INC.
39 high st.
north andover, 
MA 
01845

Correspodent Contact michael a douglas
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 12/03/2007
Decision Date 09/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No