S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K080968
Device Name S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
Applicant
ESAOTE S.P.A.
11460 n. meridian st.
suite 150
carmel, 
IN 
46032

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

Correspodent Contact carri graham
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 04/04/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No