DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE


Device Classification Name

system, image processing, radiological

510(k) Number K111385
Device Name DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
Applicant
QUBYX LIMITED
80, rue marechal joffre
nice, 

FR

06000

Applicant Contact marc leppla
Correspondent
QUBYX LIMITED
80, rue marechal joffre
nice, 

FR

06000

Correspodent Contact marc leppla
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/17/2011
Decision Date 01/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No