AYCAN WORKSTATION OSIRIX PRO


Device Classification Name

system, image processing, radiological

510(k) Number K103546
Device Name AYCAN WORKSTATION OSIRIX PRO
Applicant
AYCAN DIGITALSYSTEME GMBH
innere aumuehl strasse 5
wuerzburg, 

DE

97076

Applicant Contact matthias broenner
Correspondent
AYCAN DIGITALSYSTEME GMBH
innere aumuehl strasse 5
wuerzburg, 

DE

97076

Correspodent Contact matthias broenner
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/02/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No