A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K110802
Device Name A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
Applicant
ESAOTE S.P.A.
11460 n meridian st
suite 150
carmel, 
IN 
46032

Applicant Contact allison scott
Correspondent
ESAOTE S.P.A.
11460 n meridian st
suite 150
carmel, 
IN 
46032

Correspodent Contact allison scott
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 03/23/2011
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No