VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)


Device Classification Name

microscope, automated, image analysis, operator intervention

510(k) Number K111543
Device Name VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
Applicant
VENTANA MEDICAL SYSTEMS, INC.
919 hermosa court
sunnyvale, 
CA 
94085

Applicant Contact indu lakshman
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
919 hermosa court
sunnyvale, 
CA 
94085

Correspodent Contact indu lakshman
Regulation Number 864.1860
Classification Product Code
NOT  
Subsequent Product Code
OEO  
Date Received 06/02/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No