ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K072517
Device Name ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Applicant Contact christine dunbar
Correspondent
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Correspodent Contact christine dunbar
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 09/07/2007
Decision Date 09/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls