GENASIS HIPATH IHC FAMILY


Device Classification Name

microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity

510(k) Number K140957
Device Name GENASIS HIPATH IHC FAMILY
Applicant
APPLIED SPECTRAL IMAGING LTD.
p.o. box 4414 (a109)
caesarea, 

IL

30889

Applicant Contact ilan sharon
Correspondent
APPLIED SPECTRAL IMAGING LTD.
p.o. box 4414 (a109)
caesarea, 

IL

30889

Correspodent Contact ilan sharon
Regulation Number 864.1860
Classification Product Code
NQN  
Subsequent Product Code
NOT  
Date Received 04/14/2014
Decision Date 01/15/2015
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