SCANVIEW SYSTEM


Device Classification Name

system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays

510(k) Number K110345
Device Name SCANVIEW SYSTEM
Applicant
APPLIED SPECTRAL IMAGING
6 sireni
haifa, 

IL

10551

Applicant Contact dan laor
Correspondent
APPLIED SPECTRAL IMAGING
6 sireni
haifa, 

IL

10551

Correspodent Contact dan laor
Regulation Number 866.4700
Classification Product Code
NTH  
Date Received 02/04/2011
Decision Date 10/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01264744
Reviewed by Third Party No

Combination Product

No