Cleared Traditional

VIRTUOSO SYSTEM FOR IHC PR (IE2)

K111869 · Ventana Medical Systems, Inc. · Pathology

Mar 2012

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K111869 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC PR (IE2), a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Ventana Medical Systems, Inc. (Tucso, US). The FDA issued a Cleared decision on March 5, 2012, 248 days after receiving the submission on July 1, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K111869 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2011
Decision Date	March 05, 2012
Days to Decision	248 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.