E-SCAN


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K990968
Device Name E-SCAN
Applicant
BIOSOUND ESAOTE, INC.
8000 castleway dr.
indianapolis, 
IN 
46250

Applicant Contact colleen hittle
Correspondent
BIOSOUND ESAOTE, INC.
8000 castleway dr.
indianapolis, 
IN 
46250

Correspodent Contact colleen hittle
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 03/23/1999
Decision Date 05/27/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No