Cleared Traditional

VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

K121516 · Ventana Medical Systems, Inc. · Pathology

Sep 2013

Decision

492d

Days

Class 2

Risk

About This 510(k) Submission

K121516 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC HER2 (4B5), 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. (Los Angeles, US). The FDA issued a Cleared decision on September 26, 2013, 492 days after receiving the submission on May 22, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K121516 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2012
Decision Date	September 26, 2013
Days to Decision	492 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.