E4D COMPASS


Device Classification Name

system, image processing, radiological

510(k) Number K110511
Device Name E4D COMPASS
Applicant
D4D TECHNOLOGIES
11460 n meridian st
suite 150
carmel, 
IN 
46032

Applicant Contact allison scott
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/23/2011
Decision Date 03/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No