IBIS EXPLORER AND MARKUP SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K111319
Device Name IBIS EXPLORER AND MARKUP SOFTWARE
Applicant
MEDQIA
924 westwood blvd
suite 615
los angeles, 
CA 
90024

Applicant Contact mahtab fatemi
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/10/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No