ECHOINSIGHT


Device Classification Name

system, image processing, radiological

510(k) Number K110447
Device Name ECHOINSIGHT
Applicant
ULTRASOUND MEDICAL DEVICES, INC.
3917 research park drive
ann arbor, 
MI 
48108

Applicant Contact paul kortesoja
Correspondent
ULTRASOUND MEDICAL DEVICES, INC.
3917 research park drive
ann arbor, 
MI 
48108

Correspodent Contact paul kortesoja
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/16/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No