AURORA MR-GUIDED INTERVENTIONAL SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K023686
Device Name AURORA MR-GUIDED INTERVENTIONAL SYSTEM
Original Applicant
AURORA IMAGING TECHNOLOGY, INC.
39 high st.
north andover, 
MA 
01845

Original Contact alan oslan
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/01/2002
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No