VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)


Device Classification Name

microscope, automated, image analysis, operator intervention

510(k) Number K111755
Device Name VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e.innovation park dr.
tucson, 
AZ 
85755

Applicant Contact troy quander
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
1910 e.innovation park dr.
tucson, 
AZ 
85755

Correspodent Contact troy quander
Regulation Number 864.1860
Classification Product Code
NOT  
Subsequent Product Codes
NQN   OEO  
Date Received 06/22/2011
Decision Date 02/22/2012
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