Cleared Traditional

VIRTUOSO SYSTEM FOR IHC P53 (DO-7)

K111872 · Ventana Medical Systems, Inc. · Pathology

Apr 2012

Decision

293d

Days

Class 2

Risk

About This 510(k) Submission

K111872 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC P53 (DO-7), 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 April 19, 2012, 293 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	K111872 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2011
Decision Date	April 19, 2012
Days to Decision	293 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.