EUNITY


Device Classification Name

system, image processing, radiological

510(k) Number K111164
Device Name EUNITY
Applicant
CLIENT OUTLOOK INC
295 hagey blvd
waterloo, 

CA

n2l 6r5

Applicant Contact christie eby
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/26/2011
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No