IMACOR ZURA EVO IMAGING SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K142054
Device Name IMACOR ZURA EVO IMAGING SYSTEM
Applicant
IMACOR INC.
839 stewart ave. ste 3
garden city, 
NY 
11530

Applicant Contact james w monroe
Correspondent
IMACOR INC.
839 stewart ave. ste 3
garden city, 
NY 
11530

Correspodent Contact james w monroe
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 07/29/2014
Decision Date 09/29/2014
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No