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510(k) K140957

GENASIS HIPATH IHC FAMILY by Applied Spectral Imaging , Ltd. — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2015
Date Received
April 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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  • K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (September 29, 2006)