MODALIXX


Device Classification Name

system, image processing, radiological

510(k) Number K110108
Device Name MODALIXX
Applicant
AMPRONIX, INC.
15 whatney
irvine, 
CA 
92618

Applicant Contact asal namini
Correspondent
AMPRONIX, INC.
15 whatney
irvine, 
CA 
92618

Correspodent Contact asal namini
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/14/2011
Decision Date 03/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No