EXINI


Device Classification Name

system, image processing, radiological

510(k) Number K122205
Device Name EXINI
Applicant
EXINI DIAGNOSTICS AB
9001 wesleyan road
suite 200
inndianapolis, 
IN 
46268

Applicant Contact allison scott
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/25/2012
Decision Date 08/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No