Cleared Traditional

VIRTUOSO SYSTEM FOR IHC ER (SPI)

K130515 · Ventana Medical Systems, Inc. · Pathology

Nov 2013

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K130515 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC ER (SPI), 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 November 22, 2013, 268 days after receiving the submission on February 27, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K130515 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2013
Decision Date	November 22, 2013
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement

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.