XELIS CARDIAC


Device Classification Name

system, image processing, radiological

510(k) Number K111660
Device Name XELIS CARDIAC
Applicant
INFINITT CO., LTD.
1600 manchester way
corinth, 
TX 
76521

Applicant Contact carl alletto
Correspondent
INFINITT CO., LTD.
1600 manchester way
corinth, 
TX 
76521

Correspodent Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/14/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No