Cleared Traditional

GENASIS HIPATH IHC FAMILY

K140957 · Applied Spectral Imaging , Ltd. · Pathology

Jan 2015

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K140957 is an FDA 510(k) clearance for the GENASIS HIPATH IHC FAMILY, a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Applied Spectral Imaging , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 15, 2015, 276 days after receiving the submission on April 14, 2014. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K140957 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2014
Decision Date	January 15, 2015
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
Definition	Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.